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Medical Devices

May 2014 PMA Approvals

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P100045
5/28/14
CardioMEMS™ HF System CardioMEMS, Inc.
Atlanta, GA
30313
Approval for the CardioMEMS™ HF System, which includes the CM2000 implantable PA Sensor/Monitor and transvenous catheter delivery system, the CM1000 Patient Electronics System (GSM), the CM1010 Patient Electronics System (GSM), and CM3000 Hospital Electronics System. This device is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year.  The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.
P110005
5/9/14
Gel-Syn™ IBSA Institut Biochimique SA
Thousand Oaks, CA 91320
Approval for Gel-Syn™.  This device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g. acetaminophen).
P110027
5/23/14
therascreen® KRAS RGQ PCR Kit QIAGEN
Manchester, UK
M15 6SH
Approval for the therascreen® KRAS RGQ PCR Kit, which is to be used as a companion diagnostic for the drug Vectibix® (panitumumab). This device is indicated for: The therascreen® KRAS RGQ PCR Kit is a real-time qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene, using DNA extracted from formalin-fixed paraffin-embedded (FFPE), colorectal cancer (CRC) tissue. The therascreen® KRAS RGQ PCR Kit is intended to aid in the identification of CRC patients for treatment with Erbitux® (cetuximab) and Vectibix® (panitumumab) based on a KRAS no mutation detected test result.
P110041
5/16/14
ADVIA Centaur® HBsAgII (HBsII),
ADVIA Centaur® HBsAg Confirmatory,
ADVIA Centaur® HBsAg Quality Control Material
Siemens Healthcare Diagnostics
Tarrytown, NY
10591
Approval for the ADVIA Centaur HBsAgII, ADVIA Centaur HBsAg Confirmatory, and ADVIA Centaur HBsAg Quality Control Material. This device is indicated for:
ADVIA Centaur HBsAgII (HBsII) - The ADVIA Centaur HBsAgII (HBsII) assay is an in vitro immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult, adolescent, and pediatric serum and plasma (EDT A, lithium-heparin, or sodium-heparin), and neonatal samples using the ADVIA Centaur and ADVIA Centaur XP systems. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis B infection. The assay may also be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period.
ADVIA Centaur HBsAg Confirmatory The ADVIA Centaur HBsAg Confirmatory assay is an in vitro immunoassay for the confirmation of hepatitis B surface antigen (HBsAg) in human serum and plasma (potassium EDTA, lithium-heparin, or sodium-heparin), and neonatal samples using the ADVIA Centaur and ADVIA Centaur XP systems. The assay is intended to be used to confirm the presence of HBsAg in samples that are repeatedly reactive using the ADVIA Centaur HBsAgII assay.
ADVIA Centaur HBsAg Quality Control Material For monitoring the performance of the HBsAg, HBsAgII and HBsAg Confirmatory assays on the ADVIA Centaur systems. The performance of the HBsAg quality control material has not been established with any other HBsAg or HBsAg Confirmatory assays.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N16895/S094
5/2/14
135-Day
Soflens 38 (polymacon) soft contact lenses Bausch & Lomb
Rochester, NY 14609
Approval for an additional supplier for the raw material hydroxyethyl-methyl-methacrylate for polymacon and alphafilcon A soft contact lenses.
P830055/S143
5/23/14
Special
LCS® Total Knee System DePuy Orthopaedics, Incorporated
Warsaw, IN
46582
Approval for an additional inspection step in the manufacturing process for the Distal and Posterior Augments and the Revision Step Wedges that provides additional assurance of purity, identity, strength or reliability of the device.
P830060/S077
5/2/14
Real-Time
AID-B/BR and Ventak ICD Boston Scientific Corporation
St. Paul, MN
55112
Approval to add the use of mineral oil to device labeling.
P850048/S037
5/1/14
Real-Time
Access Hybritech PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for software changes to add process monitoring functionality to the current configuration of the Access 2 Immunoassay System through the implementation of a new software version 3.4.1.
P860003/S075
5/9/14
Real-Time
THERAKOS® CELLEX® Photopheresis System THERAKOS, Inc.
Bridgewater, NJ 08807
Approval for a change in the geometry of the stand-offs featured on the inner lower bowl cover of the CELLEX® Procedural Kit’s centrifuge bowl.
P860057/S121
5/19/14
Real-Time
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis,
Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis,
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis,
Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral Bioprosthesis,
Carpentier-Edwards PERIMOUNT Theon Pericardial Mitral Bioprosthesis,
Carpentier-Edwards PERIMOUNT Magna Mitral Pericardial Bioprosthesis,
Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis
Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements.
P870056/S067
5/19/14
Real-Time
Carpentier-Edwards Porcine Aortic Bioprosthesis,
Carpentier-Edwards Porcine Mitral Bioprosthesis,
Carpentier-Edwards Bioprosthetic Valved Conduit
Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements.
P870077/S061
5/19/14
Real-Time
Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis, Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis with Extended Suture
Ring
Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements.
P880006/S088
5/29/14
Real-Time
SENSOLOG/ DIALOG/ REGENCY PACEMAKERS St. Jude Medical
Sunnyvale, CA 94085
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650.
P880086/S242
5/29/14
Real-Time
AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT
PACEMAKERS
St. Jude Medical
Sunnyvale, CA 94085
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650.
P890003/S305
5/16/14
Real-Time
REVEAL DX. REVEAL XT, REVEAL LINQ INSERTABLE CARDIAC MONITOR Medtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices.
P890003/S306
5/23/14
Real-Time
My CareLink Patient Monitor Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P890003/S307
5/29/14
Real-Time
My CareLink Patient Monitor Medtronic, Inc.
Mounds View, MN 55112
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices.
P890055/S055
5/22/14
Special
MedStream Programmable Infusion System Codman & Shurtleff, Inc.
Raynham, MA
02767
Approval for changes to quality control and manufacturing procedures to include additional steps verifying that a minimum of 66 hours have elapsed between the time that the MedStream pump battery is connected to the Printed Circuit Board (PCB) and before programming the PCB with the production diagnostic pump software.
P890064/S030
5/12/14
Real-Time
Qiagen Digene Hybrid Capture 2 (HC2) HPV DNA Test; Qiagen Digene Hybrid Capture 2 (HC2) High Risk HPV DNA Test Qiagen Gaithersburg, Inc.
Gaithersburg, MD 20878
Approval for the upgrade of the HC2 Software Suite to Version 4.2.
P900009/S035
5/29/14
180-Day
EXOGEN Ultrasound Bone Healing System Bioventus LLC
Durham, NC
27703
Approval for a new Bioventus manufacturing facility in Cordova, Tennessee, manufacturing process changes, a rechargeable battery and charger, redesign of the main operating unit, changes to the instructions for use, and modified packaging.
P900009/S036
5/7/14
180-Day
Exogen Ultrasound Bone Healing System Bioventus LLC
Durham, NC
27703
Approval for a manufacturing site in Cordova, Tennessee.
P910023/S333
5/29/14
Real-Time
ELLIPSE/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER
DEFIBRILLATORS
St. Jude Medical
Sunnyvale, CA 94085
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650.
P910073/S124
5/2/14
Real-Time
ENDOTAK RELIANCE 4-SITE Defibrillation Leads Boston Scientific Corporation
St. Paul, MN
55112
Approval to add the use of mineral oil to device labeling.
P910077/S141
5/2/14
Real-Time
VENTAK PRx, VENTAK MINI ICDs Boston Scientific Corporation
St. Paul, MN
55112
Approval to add the use of mineral oil to device labeling.
P940015/S028
5/20/14
135-Day
Synvisc and Synvisc-One Nancy Immel
Genzyme Corporation
Cambridge, MA 02142
Approval for changes to quality control test methods.
P940031/S076
5/2/14
Real-Time
VIGOR, MERIDIAN, DISCOVERY Pacemakers Boston Scientific Corporation
St. Paul, MN
55112
Approval to add the use of mineral oil to device labeling.
P950037/S132
5/4/14
180-Day
ENTOVIS PROMRI PACEMAKER SYSTEM Biotronik, Inc.
Lake Oswego, OR 97035
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the supporting Programmer Software Version PSW 1307.U. When an Entovis Pacemaker is used in conjunction with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be identified as the Entovis ProMRI System.
P960022/S009
5/2/14
135-Day
Soflens Toric (alphafilcon A) soft Contact Lenses Bausch & Lomb
Rochester, NY 14609
Approval for an additional supplier for the raw material hydroxyethyl-methyl-methacrylate for polymacon and alphafilcon A soft contact lenses.
P960040/S310
5/2/14
Real-Time
VENTAK AV, VENTAK PRIZM, VITALITY, CONFIENT, TELIGEN, INCEPTA, ENERGEN, PUNCTUA ICDs Boston Scientific Corporation
St. Paul, MN
55112
Approval to add the use of mineral oil to device labeling.
P960040/S312
5/15/14
Real-Time
Teligen, Punctua, Energen, and Incepta Implanable Cardioverter Defibrillators (ICD) and Punctua, Energen, and Incepta Cardiac Resynchronization Therapy Defibrillators
(CRT-D)
Boston Scientific Corporation
St. Paul, MN
55112
Approval for changes in trace cobalt control limit in raw MnO2 and trace calcium control limit in raw lithium foil for the pulse generator batteries.
N970003/S159
5/2/14
Real-Time
PULSAR, PULSAR MAX, DISCOVERY, INSIGNIA, ALTRUA,
INGENIO, ADVANTIO, VITALIO, FORMIO Pacemakers
Boston Scientific Corporation
St. Paul, MN
55112
Approval to add the use of mineral oil to device labeling.
N970003/S160
5/15/14
Real-Time
Advantio and Ingenio Pacemakers Boston Scientific Corporation
St. Paul, MN
55112
Approval for changes in trace cobalt control limit in raw MnO2 and trace calcium control limit in raw lithium foil for the pulse generator batteries.
P970013/S058
5/29/14
Real-Time
MICRONY PACEMAKERS St. Jude Medical
Sunnyvale, CA 94085
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650.
P970029/S026
5/7/14
Special
TMR2000 Holmium Laser System Cardiogenesis
Kennesaw, GA 30144
Approval for including the Post Approval study labeling changes of the Pearl 8.0 device into the instructions for use of the Pearl 5.0 and the Sologrip III handpieces as well as adding some clarifying statements to ensure the safe handling of the handpieces.
P970003/S166
5/9/14
180-Day
VNS Therapy System Cyberonics, Inc.
Houson, TX
77058
Approval for labeling that describes the conditions under which Magnetic Resonance Imaging (MRI) can be used when residual VNS Leads or Lead fragments (abandoned leads) remain in the body.
P970038/S026
5/1/14
Real-Time
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for software changes to add process monitoring functionality to the current configuration of the Access 2 Immunoassay System through the implementation of a new software version 3.4.1.
P970051/S110
5/8/14
180-Day
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO 80111
Approval for a change to the assembly construction of external switches on the CP810 sound processor with the intention of improving ingress protection and therefore corrosion resistance.
P980006/S015
5/16/14
180-Day
PureVision 2 (balafilcon A) Visibility Tinted Contact Lens;
PureVision 2 for Astigmatism (balafilcon A) Visibility Tinted Contact Lens; PureVision 2 for Presbyopia (balafilcon A) Visibility Tinted Contact Lens
Bausch & Lomb, Inc.
Rochester, NY 14609
Approval for an alternate packaging solution of borate buffered saline with 0.5% poloxamine for the balafilcon A contact lens product family.
P980016/S472
5/16/14
Real-Time
EnTrust, Virtuoso, Intrinsic, Marquis, Maximo, Maximo II, Secura, Virtuoso II, Insync
Marquis, Protecta XT DR, Protecta DR, Protecta XT VR, Protecta VR, Evera XT DR,
Evera S DR, Evera XT VR, and Evera S VR
Medtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices.
P980016/S474
5/13/14
Real-Time
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD Medtronic, Inc.
Mounds View, MN 55112
Approval for a Replacement Telemetry M Component and Associated Manufacturing Changes.
P980016/S477
5/23/14
Real-Time
EVERA, INTRINSIC, MARQUIS, MAXIMO, PROTECTA, SECURA, AND VIRTUOSO II IMPLANTABLE CARDIOVERTER
DEFIBRILLATORS (ICD)
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P980016/S478
5/29/14
Real-Time
Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Intrinsic 30, Intrinsic, Marquis DR, Marquis VR, Maximo DR, Maximo II, Maximo VR, Protecta, Protecta XT, Secura, Virtuoso II DR/VR Family of ICDs Medtronic, Inc.
Mounds View, MN 55112
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices.
P980016/S479
5/23/14
Real-Time
Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD Medtronic, Inc.
Mounds View, MN 55112
Approval for the changes of the deformation element (DE) in the high voltage capacitor electrical feedthrough for the devices.
P980022/S153
5/29/14
Real-Time
Paradigm REAL-Time Revel System Medtronic MiniMed
Northridge, CA
91325
Approval for software changes to the Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-523K, MMT-723, and MMT-723K) application software. These changes include corrections for two motor error anomalies and enhancements for the Threshold Suspend feature, insulin value setting, and merged common code base. The Paradigm REAL-Time Revel Insulin Pump is a component of the Paradigm REAL-Time Revel System.
P980035/S369
5/16/14
Real-Time
Advisa DR IPO, Advisa DR MRI IPG Medtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices.
P980035/S372
5/23/14
Real-Time
ADAPTA, VERSA, SENSIA, ADVISA, ENPULSE, AND KAPPA
IMPLANTABLE PULSE GENERATORS (IPG)
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P980035/S373
5/29/14
Real-Time
Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, EnPulse E1, EnPulse E2, Kappa D, Kappa DR, Kappa SR (Kappa 700 and Kappa 900), Kappa VDD (Kappa 700) family of IPGs Medtronic, Inc.
Mounds View, MN 55112
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices.
P980041/S027
5/1/14
Real-Time
Access AFP Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for software changes to add process monitoring functionality to the current configuration of the Access 2 Immunoassay System through the implementation of a new software version 3.4.1.
P990009/S037
5/27/14
180-Day
Floseal Hemostatic Matrix Baxter Healthcare Corporation
Round Lake, IL 60073
Approval for revised labeling to include a summary of the Nasso et al. clinical trial, update the device description, and extend the Thrombin reconstitution period.
P990081/S028
5/6/14
Real-Time
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for a new adhesive for the slide heaters on the BenchMark XT and ULTRA automated slide stainers.
P000006/S034
5/5/14
180-Day
Titan Inflatable Penile Prosthesis Coloplast Corporation
Minneapolis, MN 55411
Approval for an additional raw material supplier for the polyurethane spandex material used in the fabrication of Bioflex® dispersion (used to manufacture Titan reservoirs and cylinders).
P000007/S046
5/19/14
Real-Time
Edwards Prima Plus Stentless Porcine Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements.
P000009/S057
5/4/14
180-Day
Xelos DR-T Implantable Cardioverter
Defibrillators (ICD’s)
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the supporting Programmer Software Version PSW 1307.U. When an Entovis Pacemaker is used in conjunction with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be identified as the Entovis ProMRI System.
P000029/S076
5/8/14
135-Day
Deflux Salix Pharmaceuticals, Inc.
Raleigh, NC
27615
Approval for the introduction of in-house produced water for injection (WFI), as well as clearance for the use of pharmaceutical grade NaOH and HCl, rather than the grade currently used by the firm.
P010012/S347
5/2/14
Real-Time
CONTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, INCEPTA, ENERGEN, PUNCTUA
CRT-Ds
Boston Scientific Corporation
St. Paul, MN
55112
Approval to add the use of mineral oil to device labeling.
P010012/S349
5/15/14
Real-Time
Cognis Cardiac Resynchronization Therapy Defibrillators (CRT-D) Boston Scientific Corporation
St. Paul, MN
55112
Approval for changes in trace cobalt control limit in raw MnO2 and trace calcium control limit in raw lithium foil for the pulse generator batteries.
P010013/S054
5/30/14
180-Day
NovaSure Impedance Controlled Endometrial Ablation System Hologic, Inc.
Marlborough, MA 01752
Approval of the post-approval study protocol.
P010015/S236
5/16/14
Real-Time
CONSULTA CRT-P, SYNCRA CRT-P Medtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices.
P010015/S237
5/23/14
Real-Time
CONSULTA AND SYNCRA CARDIAC RESYNCHRONI- ZATION THERAPY PACEMAKERS Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P010015/S238
5/29/14
Real-Time
Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN 55112
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices.
P010030/S049 5/19/14
Real-Time
LifeVest® Wearable Defibrillator ZOLL Lifecor Corporation
Pittsburgh, PA 15238
Approval for 29 RoHS compliant alternate components, 7 RoHS compliant alternate bare-board subassemblies, and 6 RoHS compliant alternate cable subassemblies for use in the LifeVest Wearable Defibrillator.
P010031/S433
5/16/14
Real-Time
Maximo II CRT-D, Concerto, Concerto II CRT-D, Consulta, InSync II Marquis, InSync III
Marquis, InSync Maximo, InSync Sentry, InSync Marquis, InSync II Protect, Protecta CRT-D,
Protecta XT CRT-D, Viva XT CRT-D, Viva S CRT-D, and Brava CRT-D
Medtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices.
P010031/S435
5/13/14
Real-Time
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112
Approval for a Replacement Telemetry M Component and Associated Manufacturing Changes.
P010031/S438
5/23/14
Real-Time
BRAVA, CONCERTO, CONSULTA, INSYNC, MAXIMO II,
PROTECTA, AND VIVA CARDIAC RESYNCHRONI- ZATION
THERAPY  DEFIBRILLATORS (CRT-D)
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P010031/S439
5/29/14
Real-Time
Brava CRT-D, Concerto ICD, Concerto II CRT-D, Consulta ICD, InSync II Protect ICD, InSync III Marquis ICD, InSync Maximo ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices.
P010031/S440
5/23/14
Real-Time
Brava CRT-D; Viva S CRT-D; Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112
Approval for the changes of the deformation element (DE) in the high voltage capacitor electrical feedthrough for the devices.
P010041/S050
5/19/14
Real-Time
Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements.
P020055/S014
5/6/14
Real-Time
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for a new adhesive for the slide heaters on the BenchMark XT and ULTRA automated slide stainers.
P030004/S006
5/27/14
180-Day
Onyx™ Liquid Embolic System (LES) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA
92618
Approval for the Apollo™ Onyx™ Delivery Micro Catheter that will be manufactured at Micro Therapeutics, Inc. d/b/a ev3 Neurovascular in Irvine, California.
P030005/S106
5/2/14
Real-Time
CONTAK RENEWAL TR, INVIVE, INTUA CRT-Ps Boston Scientific Corporation
St. Paul, MN
55112
Approval to add the use of mineral oil to device labeling.
P030005/S107
5/15/14
Real-Time
Invive Cardiac Resynchronization Therapy Pacemakers (CRT-P) Boston Scientific Corporation
St. Paul, MN
55112
Approval for changes in trace cobalt control limit in raw MnO2 and trace calcium control limit in raw lithium foil for the pulse generator batteries.
P030017/S186
5/22/14
180-Day
Precision Spectra SCS System Boston Scientific Corporation
Valencia, CA
91355
Approval for design changes to Precision Spectra OR Cable and Extension and an alternate qualified supplier (Onanon Inc. Milpitas, CA).
P030035/S120
5/29/14
Real-Time
FRONTIER/
FRONTIER II/ ANTHEM CARDIAC
RESYNCHRONI-
ZATION THERAPY-PACEMAKERS
St. Jude Medical
Sunnyvale, CA 94085
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650.
P030054/S265
5/29/14
Real-Time
QUADRA ASSURA/UNIFY ASSURA CARDIAC
RESYNCHRONI-ZATION THERAPY-DEFIBRILLATORS
St. Jude Medical
Sunnyvale, CA 94085
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650.
P050010/S014
5/28/14
180-Day
PRODISC L Total Disc Replacement DePuy Synthes Spine
Raynham, MA 02767
Approval to add additional endplates as a line extension.
P050023/S074
5/4/14
180-Day
Ilesto implantable cardioverter
defibrillators (ICD’s) and cardiac resynchronization therapy defibrillators
(CRT-D’s)
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the supporting Programmer Software Version PSW 1307.U. When an Entovis Pacemaker is used in conjunction with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be identified as the Entovis ProMRI System.
P050050/S007
5/9/14
180-Day
Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle) Small Bone Innovations, Inc.
Morrisville, PA
19067
Approval of the post-approval study protocol.
P060019/S025
5/19/14
180-Day
Therapy Cool Path Ablation Catheter & IBI-1500T9 RF Generator – Cool Point™ Tubing Set Irvine Biomedical, Inc.
Irvine, CA
92614
Approval for a design change in the tubing set material and package size for the Cool Point™ Tubing Set.
P060037/S027
5/13/14
135-Day
NexGen LPS Flex Mobile Bearing Knee Zimmer, Incorporated
Warsaw, IN
46581
Approval for new testing equipment.
P060037/S028
5/22/14
135-Day
NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee Zimmer, Incorporated
Warsaw, IN
46581
Approval for addition of a new manufacturing area with new equipment.
P070008/S050
5/4/14
180-Day
Evia cardiac resynchronization therapy
pacemakers
(CRT-P’s)
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the supporting Programmer Software Version PSW 1307.U. When an Entovis Pacemaker is used in conjunction with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be identified as the Entovis ProMRI System.
P070015/S119
5/29/14
135-Day
XIENCE V® Everolimus Eluting Coronary Stent System (RX and OTW);
XIENCE nano™ Coronary Stent System (RX)
Abbott Vascular
Temecula, CA 92589
Approval for a change in the resin composition of polypropylene supply items used in XIENCE primer and drug formulation manufacturing.
P070026/S021
5/19/14
180-Day
Ceramax Ceramic Hip System Depuy, Inc.
Warsaw, IN
46581
Approval of the post-approval study protocol.
P080006/S063
5/15/14
180-Day
Attain Ability Lead Medtronic CRDM
Mounds View, MN 55112
Approval for changes to the monolithic controlled release device (MCRD) elution method and specifications, transfer of the MCRD manufacturing location, use of a surrogate tip component for MCRD testing, and updates to the MCRD shelf life protocol for Attain Ability lead models 4196, 4296 and 4396.
P090013/S136
5/16/14
Real-Time
Revo MRI Medtronic, Inc.
Mounds View, MN
55112
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices.
P090013/S138
5/23/14
Real-Time
REVO MRI IPG Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink Patient Monitor 24950.
P090013/S139
5/29/14
Real-Time
Revo MRI IPG Medtronic, Inc.
Mounds View, MN 55112
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices.
P090026/S010
5/1/14
Real-Time
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for software changes to add process monitoring functionality to the current configuration of the Access 2 Immunoassay System through the implementation of a new software version 3.4.1.
P100003/S003
5/8/14
180-Day
Secure-C Artificial Cervical Disc Globus Medical, Inc.
Audubon, PA
19403
Approval of the post-approval study protocol.
P100009/S005
5/22/14
Special
MitraClip & Clip Delivery System Abbott Vascular
Menlo Park, CA 94025
Approval for a labeling change that included additions to the list of anticipated events and converting certain procedural caution statements to warning statements.
P100014/S012
5/12/14
135-Day
Solesta Salix Pharmaceuticals, Inc.
Raleigh, NC
27615
Introduction of in-house produced water for injection (WFI).
P100021/S035
5/13/14
Special
Endurant and Endurant II Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403
Approval for clarifications made to the rear handle assembly manufacturing process procedures.
P100021/S036
5/14/14
Special
Endurant and Endurant II Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403
Approval for minor clarifications to the hydrophilic coating procedures.
P100023/S080
5/19/14
135-Day
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific
Maple Grove, MN 55311
Approval to reduce the Kinetic Drug Release (KDR) sample quantity for batch release and stability testing.
P100026/S011
5/7/14
Real-Time
RNS® System NeuroPace, Inc.
Mountain View, CA 94043
Approval for the addition of Ethernet connectivity to access the Patient Data Management System database.
P100027/S017
5/6/14
Real-Time
INFORM HER2 Dual ISH DNA Probe Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for a new adhesive for the slide heaters on the BenchMark XT and ULTRA automated slide stainers.
P100029/S015
5/8/14
135-Day
Trifecta™ Valve St. Jude Medical, Inc.
St. Paul, MN
55117
Approval for an alternate bacterial endotoxin sampling/testing plan for the Trifecta™ valve.
P100041/S050
5/19/14
Real-Time
Edwards SAPIEN Transcatheter Heart Valve and Accessories Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements.
P110002/S001
5/27/14
180-Day
Mobi-C Cervical Disc LDR Spine USA, Inc.
Austin, TX
78750
Approval of the post-approval study protocol.
P110004/S002
5/1/14
Real-Time
NIRxcell CoCr Coronary Stent on RX System Medinol Ltd.
Tel Aviv, Israel
61581
Approval for a modification to the D-catheter tip spring.
P110009/S001
5/19/14
180-Day
Mobi-C Cervical Disc LDR Spine USA, Inc.
Austin, TX
78750
Approval of the post-approval study protocol.
P110009/S002
5/8/14
180-Day
Mobi-C Cervical Disc LDR Spine USA, Inc.
Austin, TX
78750
Approval of the post-approval study protocol.
P110014/S002
5/15/14
180-Day
MarginProbe System Dune Medical, Ltd.
Caesarea Industrial Park, Israel
38900
Approval for a manufacturing site located at Medimor Ltd., in Tiberias, Israel (contract manufacturer).
P110019/S060
5/29/14
135-Day
XIENCE PRIME® Everolimus Eluting Coronary Stent System (RX);
XIENCE PRIME® Everolimus Eluting Coronary Stent System, LL (RX);
XIENCE XPEDITION™ Everolimus Eluting Coronary Stent System (RX and OTW); XIENCE XPEDITION™
Everolimus Eluting Coronary Stent System, SV (RX and OTW); XIENCE XPEDITION™ Everolimus Eluting
Coronary Stent System, LL (RX and OTW)
Abbott Vascular
Temecula, CA 92589
Approval for a change in the resin composition of polypropylene supply items used in XIENCE primer and drug formulation manufacturing.
P110021/S037
5/19/14
Real-Time
Edwards SAPIEN Transcatheter Heart Valve and Accessories Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N970003/S162
5/12/14
ADVANTIO™ Implantable Pulse Generator (PG);
INGENIO™ PG; VITALIO™ PG; FORMIO™ PG
Boston Scientific Corporation
St. Paul, MN
55112
Adding an alternate Oscillator Crystal component to hybrid bill of materials for the devices.
N970003/S163
5/28/14
ADVANTIO; INGENIO; VITALIO; FORMIO Pacemaker Boston Scientific Corporation
Saint Paul, MN 55112
Use an alternate inspection method and equipment with a corresponding specification change.
N970003/S164
5/23/14
FORMIO, VITALIO, ADVANTIO, INGENIO Pacemakers Boston Scientific Corporation
Saint Paul, MN 55112
Addition of a second Pulse Generator (PG) device header overmolding Main Line 2 at the Clonmel manufacturing facility.
P790002/S032
5/9/14
Biomet EBI Bone Healing System EBI, LLC, d/b/a Biomet Spine & Bone Healing Technologies
Parsippany, NJ 07054
Addition of new labeling equipment.
P790007/S041
5/19/14
Hancock® Modified Orifice Valved Conduit Medtronic Heart Valves
Santa Ana, CA 92705
Addition of new porcine tissue suppliers.
P810006/S052
5/7/14
Collastat Absorbable Collagen Hemostatic Sponge, Collastat
Absorbable Collagen Hemostatic Agent - Microfibrillar Form
Integra Life Sciences Corporation
Plainsboro, NJ 08536
Qualification of a new AirLock Room.
P830060/S079
5/7/14
Suture Sleeve, Lead Cap, Medical Adhesive, Stylet Boston Scientific Corporation
St. Paul, MN
55112
Add an identical Sterilization Chamber to the St. Paul manufacturing facility.
P840001/S268
5/23/14
SCS Neurostimulators Implantable Restore Family Medtronic, Inc.
Minneapolis, MN 55432
Update the software used at the Medtronic Tempe Campus.
P840062/S039
5/7/14
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound
Dressings for Dental Surgery
Integra Life Sciences Corporation
Plainsboro, NJ 08536
Qualification of a new AirLock Room.
P850010/S052
5/7/14
Helistat, Helitene Absorbable Collagen Hemostatic Agents Integra Life Sciences Corporation
Plainsboro, NJ 08536
Qualification of a new AirLock Room.
P850022/S022
5/9/14
Biomet OrthoPak Non-invasive Bone Growth Stimulator System & Biomet SpinalPak Non-invasive Spine Fusion Stimulator System EBI, LLC, d/b/a Biomet Spine & Bone Healing Technologies
Parsippany, NJ 07054
Addition of new labeling equipment.
P850068/S010
5/14/14
Silsoft® (elastofilcon A) Contact Lenses Bausch & Lomb, Inc.
Rochester, NY 14609
Acceptance of an alternate autoclave.
P850068/S011
5/8/14
Silsoft (Elastofilcon A) Contact Lens Bausch & Lomb, Inc.
Rochester, NY 14609
Replacement of the laser etching system.
P860057/S123
5/1/14
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprostheses Edwards Lifesciences, LLC
Irvine, CA
92614
Addition of an alternate tissue supplier.
P860057/S24
5/13/14
Carpentier-Edwards PERIMOUNT Pericardia Aortic and Mitral Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Upgrade of the valve flow and leaflet coaptation tester.
P870078/S025
5/19/14
Hancock® Low Porosity Valved Conduit Medtronic Heart Valves
Santa Ana, CA 92705
Addition of new porcine tissue suppliers.
P890003/S308
5/2/14
MyCareLink Patient Monitor Medtronic, Inc.
Mounds View, MN 55112
Test changes to the telemetry module.
P900033/S034
5/7/14
Integra Dermal Regeneration Template Integra Life Sciences Corporation
Plainsboro, NJ 08536
Qualification of a new AirLock Room.
P900056/S137
5/1/14
Rotablator Rotational Atherectomy System Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P900056/S138
5/5/14
Rotablator Rotational Atherectomy System Boston Scientific Corporation
Maple Grove, MN 55311
Change to the Incoming Inspection site for the Rotablator Console components from Fremont, California to San Jose, California.
P910007/S043
5/16/14
ARCHITECT Total Free PSA Abbott Laboratories Abbott Park, IL 60064 Revision of the quality control test method to allow the AxSYM Total and Free PSA test methods to be replaced by the ARCHITECT Total and Free PSA test methods for the manufacture of PSA Panel H.
P910007S044
5/28/14
ARCHITECT Total PSA Abbott Laboratories, Abbott Park, IL 60064 Changes to the quality control testing used to assess the suitability of in-process ARCHITECT Total PSA bulk secondary calibrator materials and ARCHITECT Free PSA bulk product calibrator/ control materials.
P910023/S334
5/19/14
FORTIFY AND FORTIFY ASSURA FAMILIES OF ICD DEVICES St. Jude Medical
Sylmar, CA
91342
Change to the integrated circuit component rework procedure.
P910023/S335
5/23/14
Current DR, Current DR RF, Current Accel DR, Current+ DR, Current VR, Current VR RF, Current Accel VR, Current+ VR, Ellipse DR, Ellipse VR, Fortify DR, Fortify VR, Fortify Assura DR, Fortify Assura VR St. Jude Medical
Sylmar, CA
91342
Use of an alternate electrolyte supplier for the high voltage capacitors used in the devices.
P910062/S004
5/30/14
STAR S41R Excimer Laser System and WaveScan WaveFront System AMO Manufacturing USA, LLC
Milpitas, CA
95035
Change of the Frame Grabber Printed Circuit Board (PCB) of the STAR system.
P910062/S006
5/30/14
STAR S4 IR Excimer Laser System and WaveScan WaveFront System AMO Manufacturing USA, LLC
Milpitas, CA
95035
Addition of a re-polishing process for the Hex Prism assembly, of the STAR system.
P910073/S125
5/7/14
ENDOTAK TRANSVENOUS DEFIBRILLATION SYSTEM Boston Scientific Corporation
St. Paul, MN
55112
Add an identical Sterilization Chamber to the St. Paul manufacturing facility.
P910077/S142
5/7/14
VENTAK PRX AICD SYSTEM. PRESCRIPTOR PROGRAMMER AND PROGRAM AND PROGRAM DISK Boston Scientific Corporation
St. Paul, MN
55112
Add an identical Sterilization Chamber to the St. Paul manufacturing facility.
P920047/S069
5/1/14
Blazer II Cardiac Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P920047/S070
5/30/14
Blazer II, Blazer II HTD, Blazer Prime HTD Temperature Ablation
Catheters
Boston Scientific Corporation
Maple Grove, MN 55311
Acceptance to replace an existing manual process with an automated process.
P930016/S040
5/30/14
STAR S41R Excimer Laser System and WaveScan WaveFront System AMO Manufacturing USA, LLC
Milpitas, CA
95035
Change of the Frame Grabber Printed Circuit Board (PCB) of the STAR system.
P930016/S042
5/30/14
STAR S4 IR Excimer Laser System and WaveScan WaveFront System AMO Manufacturing USA, LLC
Milpitas, CA
95035
Addition of a re-polishing process for the Hex Prism assembly, of the STAR system.
P930029/S043
5/16/14
Atakr® Radio Frequency (RF) Catheter Ablation System Medtronic, Inc.
Mounds View, MN 55112
Change to the process controls on the part of a supplier to verify insulation between thermocouple double wires.
P930031/S052
5/23/14
WALLSTENT TIPS Endoprosthesis Boston Scientific Corp.
Maple Grove, MN 55311
Relocation of the manufacturing for the E-tube component from one Boston Scientific Corporation facility to another.
P930035/S026
5/7/14
VENTAK P2 AICD SYSTEM Boston Scientific Corporation
St. Paul, MN
55112
Add an identical Sterilization Chamber to the St. Paul manufacturing facility.
P930039/S108
5/28/14
CapSureFix Novus Lead Medtronic CRDM
Mounds View MN 55112
Tip grinding process improvement for helix components.
P940008/S031
5/7/14
RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS Boston Scientific Corporation
St. Paul, MN
55112
Add an identical Sterilization Chamber to the St. Paul manufacturing facility.
P940015/S032
5/14/14
Synvisc and Synvisc-One Genzyme Corporation
Ridgefield, NJ
07657
Addition of an automated system.
P940019/S044
5/23/14
WALLSTENT Iliac Endoprosthesis Boston Scientific Corp.
Maple Grove, MN 55311
Relocation of the manufacturing for the E-tube component from one Boston Scientific Corporation facility to another.
P940031/S077
5/7/14
VIGOR DR PACEMAKER SYSTEM/VIGOR SR PACEMAKER SYSTEM Boston Scientific Corporation
St. Paul, MN
55112
Add an identical Sterilization Chamber to the St. Paul manufacturing facility.
P960004/S065
5/7/14
THINLINE AND FINELINE TRANSVENOUS ENDOCARDIAL PACING LEADS Boston Scientific Corporation
St. Paul, MN
55112
Add an identical Sterilization Chamber to the St. Paul manufacturing facility.
P960006/S042
5/7/14
FLEXTEND PACING LEADS AND FIXATION TOOL Boston Scientific Corporation
St. Paul, MN
55112
Add an identical Sterilization Chamber to the St. Paul manufacturing facility.
P960009/S194
5/23/14
DBS Neurostimulators Implantable Activa Family Medtronic, Inc.
Minneapolis, MN 55432
Update the software used at the Medtronic Tempe Campus.
P960011/S024
5/27/14
BVI 1% Ophthalmic Viscosurgical Devices (OVD) Ferring Pharmaceuticals, Inc.
Parisippany, NJ 07054
Use of a new intermediate vessel for BVI 1% and EUFLEXXA OVD.
P960040/S313
5/1/14
PUNCTUA ICDs, TELIGEN ICDs, ENERGEN ICDs, INCEPTA ICDs Boston Scientific Corporation
St. Paul, MN
55112
Manufacturing changes to the capacitor parylene measurement.
P960040/S314
5/28/14
PUNCTUA ICDs; TELIGEN ICDs; ENERGEN ICDs; INCEPTA ICDs; ORIGEN ICDs; INOGEN ICDs; DYNAGEN ICDs Boston Scientific Corporation
Saint Paul, MN 55112
Use an alternate inspection method and equipment with a corresponding specification change.
P960040/S315
5/23/14
DYNAGEN, INOGEN, ORIGEN ICDs Boston Scientific Corporation
Saint Paul, MN 55112
Addition of a second Pulse Generator (PG) device header overmolding Main Line 2 at the Clonmel manufacturing facility.
P970020/S080
5/13/14
MULTI-LINK ULTRA®/ MULTI-LINK ZETA® Coronary Stent
Systems
Abbott Vascular
Temecula, CA 92591
Addition of receiving inspection and testing activities of raw materials and supply items at the Clonmel, Ireland facility and contract laboratories.
P970031/S045
5/19/14
Freestyle® Aortic Root Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Addition of new porcine tissue suppliers.
P970051/S119
5/16/14
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO 80111
Acceptance of a new surgical instrument supplier.
P980003/S049
5/1/17
Chilli II Cooled Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P980007/S034
5/16/14
ARCHITECT Free PSA Abbott Laboratories Abbott Park, IL 60064 Revision of the quality control test method to allow the AxSYM Total and Free PSA test methods to be replaced by the ARCHITECT Total and Free PSA test methods for the manufacture of PSA Panel H.
P980007/S035
5/13/14
ARCHITECT Free PSA Abbott Laboratories, Abbott Park, IL 60064 Changes to quality control testing used on in- process materials-ARCHITECT Free PSA bulk secondary calibrators and ARCHITECT Free PSA bulk product calibrators/controls.
P980016/S480
5/2/14
Evera ICDs Medtronic, Inc.
Mounds View, MN 55112
Test changes to the telemetry module.
P980016/S482
5/22/14
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN 55112
Update to the Next Generation Hybrid Tester process.
P980016/S483
5/30/14
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN 55112
Change in the AVX capacitor lapping process used in the devices.
P980022/S155
5/14/14
Paradigm REAL-Time Continuous Glucose Monitoring System, Paradigm REAL-Time Revel Continuous Glucose Monitoring System,
Guardian REAL-Time Continuous Glucose Monitoring System
Medtronic MiniMed
Northridge, CA  91325
New tool to be used in the process of curing the vibrator motor to the vibrator motor housing in the Paradigm REAL-Time Insulin Pump (Models: MMT-522, MMT-522K, MMT-722, MMT-722K), a component of the Paradigm REAL-Time Continuous Glucose Monitoring System, the Paradigm REAL-Time Revel Insulin Pump (Models: MMT-523, MMT-523K, MMT-723, MMT-723K), a component of the Paradigm REAL-Time Revel Continuous Glucose Monitoring System, and the Guardian REAL-Time Continuous Glucose Monitoring System.
P980033/S041
5/23/14
WALLSTENT Venous Endoprosthesis Boston Scientific Corp.
Maple Grove, MN 55311
Relocation of the manufacturing for the E-tube component from one Boston Scientific Corporation facility to another.
P980035/S375
5/15/14
Advisa DR IPG, Advisa DR MRI IPG Medtronic CRDM
Mounds View, MN 55112
Antenna wire bond coat manufacturing standardization for the devices.
P980035/S376
5/29/14
Advisa DR and Advisa DR MRI IPGs Medtronic, Inc.
Mounds View, MN 55112
Changes to the leak test system.
P980043/S045
5/19/14
Hancock® II Porcine Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Addition of new porcine tissue suppliers.
P980044/S018
5/30/14
SUPARTZ Seikagaku Corporation
Tokyo, Japan
100-0005
Addition of two new raw material storage rooms.
P990010/S004
5/30/14
STAR S41R Excimer Laser System and WaveScan WaveFront System AMO Manufacturing USA, LLC
Milpitas, CA
95035
Change of the Frame Grabber Printed Circuit Board (PCB) of the STAR system.
P990010/S006
5/30/14
STAR S4 IR Excimer Laser System and WaveScan WaveFront System AMO Manufacturing USA, LLC
Milpitas, CA
95035
Addition of a re-polishing process for the Hex Prism assembly, of the STAR system.
P990064/S054
5/19/14
Mosaic® Porcine Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Addition of new porcine tissue suppliers.
P000020/S018
5/16/14
Bard Ablation System Boston Scientific Corporation
Lowell, MA
01851
Acceptance to implement an additional supplier to perform machining of the ablation catheter handle components.
P000023/S010
5/21/14
Fossa-Eminence and Condylar Prothesis System Nexus CMF, LLC
Salt Lake City, UT 84212
Add water quality standards.
P000029/S077
5/21/14
Deflux Injectable Gel Salix Pharmaceuticals, Inc.
Raleigh, NC
27615
Expansion of the  firm’s clean room production area.
P000035/S010
5/21/14
TMJ Fossa-Eminence Prosthesis System Nexus CMF, LLC
Salt Lake City, UT 84212
Add water quality standards.
P010012/S350
5/1/14
PUNCTUA CRT-D, COGNIS CRT-Ds,
ENERGEN CRT-Ds, INCEPTA
CRT-Ds
Boston Scientific Corporation
St. Paul, MN
55112
Manufacturing changes to the capacitor parylene measurement.
P010012/S351
5/12/14
INVIVE™ Cardiac Resynchronization Therapy Pacemaker (CRT-P); INTUA™ CRT-P Boston Scientific Corporation
St. Paul, MN
55112
Adding an alternate Oscillator Crystal component to hybrid bill of materials for the devices.
P010012/S352
5/7/14
CONTAK CD CRT-D &EASYTRAK CORONARY VENOUS STEROID ELUTING SINGLE ELCTRODE PACE/SENSE LEAD Boston Scientific Corporation
St. Paul, MN
55112
Add an identical Sterilization Chamber to the St. Paul manufacturing facility.
P010012/S353
5/28/14
PUNCTUA CRT-Ds; COGNIS CRT-Ds; ENERGEN CRT-Ds; INCEPTA CRT-Ds; ORIGEN CRT-Ds; INOGEN CRT-Ds; DYNAGEN Boston Scientific Corporation
Saint Paul, MN 55112
Use an alternate inspection method and equipment with a corresponding specification change.
P010012/S354
5/23/14
DYNAGEN, INOGEN, ORIGEN CRT-Ds Boston Scientific Corporation
Saint Paul, MN 55112
Addition of a second Pulse Generator (PG) device header overmolding Main Line 2 at the Clonmel manufacturing facility.
P010013/S055
5/14/14
NovaSure Impedance Controlled Endometrial Ablation System Hologic, Inc.
Marlborough, MA 01752
Change in the leak test performed on the RF controller manifold subassembly.
P010015/S239
05/29/14
Consulta and Syncra Cardiac Resynchronization Therapy - Pacemakers Medtronic, Inc.
Mounds View, MN 55112
Changes to the leak test system.
P010015/S240
5/28/14
Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View MN, 55112
Add an additional ultrasonic weld (USW) to connect the connector sub-assembly to the radiopaque component.
P010029/S020
5/27/14
EUFLEXXA Ophthalmic Viscosurgical Devices (OVD) Ferring Pharmaceuticals, Inc.
Parisippany, NJ 07054
Use of a new intermediate vessel for BVI 1% and EUFLEXXA OVD.
P010031/S441
5/2/14
Brava, Viva
CRT-Ds
Medtronic, Inc.
Mounds View, MN 55112
Test changes to the telemetry module.
P010031/S444
5/22/14
Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D Medtronic, Inc.
Mounds View, MN 55112
Update to the Next Generation Hybrid Tester process.
P010031/S445
5/30/14
Brava CRT-D, Concerto II CRT-D,
Consulta ICD,
Maximo II CRT-D, Protecta CRT-D, Protecta XT
CRT-D, Viva S CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Change in the AVX capacitor lapping process used in the devices.
P010033/S024
5/22/14
QuantiFERON®-TB Gold In-Tube Cellestis Incorporated
Valencia, CA
91355
Change to the location of manufacturing activities within the same previously approved establishment for the Contract Manufacturing Organization.
P020004/S093
5/2/14
GORE® EXCLUDER® AAA Endoprosthesis W.L. Gore & Associates, Inc.
Phoenix, AZ
85085
Addition of an automated dual head wrapper.
P020004/S094
5/28/14
EXCLUDER AAA Endoprosthesis W.L. Gore & Associates, Inc.
Phoenix, AZ
85085
New supplier for biological indicators.
P020009/S121
5/1/14
Express2 Monorail and OTW Coronary Stent System Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P020025/S057
5/1/14
Blazer II XP Cardiac Ablation Catheter and Cable Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P020025/S058
5/30/14
Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP Temperature Ablation
Catheters
Boston Scientific Corporation
Maple Grove, MN 55311
Acceptance to replace an existing manual process with an automated process.
P020036/S028
5/12/14
SMART Control Nitinol Stent Systems Cordis Corporation
Fremont, CA
94555
Change in manufacturing facility for the supplier of the slider assembly and handle and the introduction of a new molding machine.
P020045/S053
5/14/14
Freezor, Freezor MAX and Freeze Xtra Cryoablation Devices Medtronic CryoCath LP
Quebec, Canada
H9R 5Z8
Change to the type of test catheter used during Cryoconsole manufacturing and field installation testing.
P020047/S008
5/13/14
MULTI-LINK VISION®/ MULTI-LINK MINI VISION®/
MULTI-LINK 8® Coronary Stent Systems
Abbott Vascular
Temecula, CA 92591
Addition of receiving inspection and testing activities of raw materials and supply items at the Clonmel, Ireland facility and contract laboratories.
P030002/S031
5/13/14
Crystalens and Trulign Toric Intraocular Lens Bausch & Lomb, Inc.
Irvine, CA
92618
Acceptance of a microbiological testing facility and the repurposing of a manufacturing room.
P030005/S109
5/28/14
INVIVE CRT Ps; INTUA CRT Ps Boston Scientific Corporation
Saint Paul, MN 55112
Use an alternate inspection method and equipment with a corresponding specification change.
P030005/S110
5/23/14
INVIVE, INTUA CRT-Ps Boston Scientific Corporation
Saint Paul, MN 55112
Addition of a second Pulse Generator (PG) device header overmolding Main Line 2 at the Clonmel manufacturing facility.
P030009/S077
5/2/14
Integrity Coronary Stent Systems Medtronic Inc.
Santa Rosa, CA 95403
Upgrade to the Wire Forming machine that is currently used on Integrity stents.
P030009/S078
5/23/14
Integrity Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Change to the stent sub-assembly manufacturing equipment.
P030017/S194
5/2/14
Precision Spectra Spinal Cord Stimulator System Boston Scientific Corporation
Valencia, CA
91355
Add an alternate wire bonder.
P030017/S195
5/2/14
Precision Spectra Spinal Cord Stimulator System Boston Scientific Corporation
Valencia, CA
91355
Add an alternate qualified supplier for thick film resistors.
P030022/S030
5/30/14
REFLECTION Ceramic Acetabular Hip System (RCHS) Smith & Nephew, Inc.
Memphis, TN 38116
Introduce a new tray sealer to the packaging process.
P030054/S266
5/19/14
QUADRA ASSURA, UNIFY, UNIFY ASSURA St. Jude Medical
Sylmar, CA
91342
Change to the integrated circuit component rework procedure.
P030054/S267
5/23/14
Promote, Promote
Accel, Promote RF, Promote Q, Promote
Quadra, Promote+,
Quadra Assura, Unify, Unify Assura, Unify Quadra
St. Jude Medical
Sylmar, CA
91342
Use of an alternate electrolyte supplier for the high voltage capacitors used in the devices.
P040016/S127
5/1/14
VeriFLEX (Liberté) Coronary Stent System Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P040027/S033
5/28/14
VIATORR TIPS Endoprosthesis W.L. Gore & Associates, Inc.
Phoenix, AZ
85085
New supplier for biological indicators.
P040037/S063
5/28/14
VIABAHN Endoprosthesis W.L. Gore & Associates, Inc.
Phoenix, AZ
85085
New supplier for biological indicators.
P040043/S061
5/28/14
TAG Thoracic Endoprosthesis W.L. Gore & Associates, Inc.
Phoenix, AZ
85085
New supplier for biological indicators.
P040044/S053
5/1/14
Mynx® Vascular Closure Device Product Family Access Closure, Inc.
Santa Clara, CA 95054
Implementation of a different sterilization configuration for the Mynx® Product Family of devices.
P040044/S055
5/8/14
Mynx Vascular Closure Device Product Family Access Closure, Inc.
Santa Clara, CA 95054
Manufacturing process changes for cutting and drying the Hydrogel cakes of the Mynx Vascular Closure Device Product Family.
P050006/S038
5/28/14
HELEX Septal Occluder W.L. Gore & Associates, Inc.
Phoenix, AZ
85085
New supplier for biological indicators.
P050033/S017
5/22/14
Hydrelle Anika Therapeutics, Incorporated
Bedford, MA
02110
Transfer of residual solvent release testing from S&N Laboratories to in-house testing at Anika Therapeutics.
P050037/S048
5/7/14
Radiesse Dermal Filler Merz North America, Inc.
Franksville, WI 53126
Automation of the filling process for the Radiesse product.
P050052/S053
5/7/14
Radiesse Dermal Filler Merz North America, Inc.
Franksville, WI 53126
Automation of the filling process for the Radiesse product.
P060006/S059
5/1/14
Express SD Renal Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P060040/S035
5/6/14
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA 94588
Addition of a supplier for the sintering process for the HeartMate II LVAS components.
P070015/S123
5/13/14
XIENCE V® Everolimus Eluting Coronary Stent Systems Abbott Vascular
Temecula, CA 92591
Addition of receiving inspection and testing activities of raw materials and supply items at the Clonmel, Ireland facility and contract laboratories.
P080012/S020
5/22/14
Prometra Programmable Infusion Pump System Flowonix Medical, Inc.
Mount Olive, NJ 07828
Alternate Electronic Modules Random Access Memory (RAM).
P080020/S007
5/30/14
Gel-One Seikagaku Corporation
Tokyo, Japan
100-0005
Addition of two new raw material storage rooms.
P090013/S140
5/15/14
Revo MRI IPG Medtronic CRDM
Mounds View, MN 55112
Antenna wire bond coat manufacturing standardization for the devices.
P090013/S141
5/29/14
REVO MRI Implantable Pulse Generators (IPG) Medtronic, Inc.
Mounds View, MN 55112
Changes to the leak test system.
P090013/S142
5/28/14
CapSureFix MRI Lead Medtronic CRDM
Mounds View MN, 55112
Tip grinding process improvement for helix components.
P100021/S034
5/6/14
Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403
Change to the sterilization load configuration.
P100021/S037
5/23/14
Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403
Relocation of a second tier supplier of a critical component.
P100023/S094
5/1/14
ION (Taxus Element) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P100023/S095
5/1/14
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Monorail and Over-the-Wire Boston Scientific Corporation
Maple Grove, MN 55311
Change to the stent inspection requirements.
P100023/S097
5/22/14
ION™ Paclitaxel- Eluting Coronary Stent System (Monorail and Over-The-Wire Systems) Boston Scientific Corporation
Maple Grove, MN 55311
Change to use a color camera for the distal tip inspection process.
P100026/S016
5/1/14
Neuropace RNS System NeuroPace, Inc.
Mountain View, CA 94043
Add alternate equipment.
P100040/S019
5/6/14
Valiant Stent Graft with the Captivia Delivery System Medtronic Vascular
Santa Rosa, CA 95403
Change to the sterilization load configuration.
P100041/S052
5/1/14
Edwards SAPIEN® Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Addition of an alternate tissue supplier.
P100041/S053
5/16/14
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories Edwards Lifesciences, LLC
Irvine, CA
92614
Changes to the manufacturing fixtures used in the manufacturing of the RetroFlex 3 Delivery System.
P100044/S016
5/23/14
Propel and Propel Mini Sinus Implants Intersect ENT
Menlo Park, CA 94025
Addition of a new pouch sealing equipment, Sencorp White Heat Sealer with Vaccuum and Gas Purge Model 12-PV/2, to the existing manufacturing line for the packaging of the Propel and Propel Mini Sinus Implants.
P110002/S006
5/2/14
LDR Spine
Mobi-C® Cervical Disc Prosthesis for use at One or Two Levels
LDR Spine USA, Inc.
Austin, TX
78750
Modifications to several final inspections.
P110004/S003
5/12/14
NIRxcell CoCr Coronary Stent on RX System Medinol Ltd.
Tel Aviv, Israel
61581
Addition of a new clean room to the Medinol Jerusalem manufacturing plant.
P110009/S006
5/2/14
LDR Spine
Mobi-C® Cervical Disc Prosthesis for use at One or Two Levels
LDR Spine USA, Inc.
Austin, TX
78750
Modifications to several final inspections.
P110010/S079
5/1/14
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P110010/S080
5/1/14
PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System Monorail and Over-the-Wire Boston Scientific Corporation
Maple Grove MN 55311
Change to the stent inspection requirements.
P110010/S082
5/12/14
PROMUS Element™ Plus/Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Upgrade to the current Integrated Crimp and Cone Puff (ICCP) machines such that functionalities associated with the Non-Contact Measurement System (NCMS) will be combined with the ICCP on one machine.
P110010/S084
5/22/14
PROMUS® Element™ Plus Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Change to use a color camera for the distal tip inspection process.
P110013/S039
5/2/14
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Inc.
Santa Rosa, CA 95403
Upgrade to the Wire Forming machine that is currently used on Integrity stents.
P110013/S040
5/23/14
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Change to the stent sub-assembly manufacturing equipment.
P110019/S067
5/13/14
XIENCE PRIME®/XIENCE Xpedition® Everolimus Eluting
Coronary Stent Systems
Abbott Vascular
Temecula, CA 92591
Addition of receiving inspection and testing activities of raw materials and supply items at the Clonmel, Ireland facility and contract laboratories.
P110021/S039
5/1/14
Edwards SAPIEN® Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Addition of an alternate tissue supplier.
P110021/S040
5/16/14
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories Edwards Lifesciences, LLC
Irvine, CA
92614
Changes to the manufacturing fixtures used in the manufacturing of the RetroFlex 3 Delivery System.
P110035/S025
5/14/14
Epic Vascular Self-Expanding Stent System Boston Scientific Corp.
Maple Grove, MN 55311
Changes to the ethylene oxide sterilization process.
P110035/S027
5/23/14
Epic Vascular Self-Expanding Stent System Boston Scientific Corp.
Maple Grove, MN 55311
Relocation of the manufacturing for the E-tube component from one Boston Scientific Corporation facility to another.
P110042/S033
5/28/14
Subcutaneous Implantable Defibrillator
(S-ICD) System
Cameron Health, Inc.
San Clemente, CA 92673
Transfer the final package for the EIT from Cameron to Cameron’s contract manufacturer Boston Scientific Corporation (BSC).
P110042/S034
5/29/14
Subcutaneous Implantable Defibrillator
(S-ICD) System
Cameron Health, Inc.
San Clemente, CA 92673
Add a dropout voltage variation test in the manufacturing process for the S-ICD pulse generator.
P110042/S035
5/30/14
SQ-RX Pulse Generator Boston Scientific CRM
St. Paul, MN
55112
Changes related to manufacturing process of the battery including qualifying a new weld machine, modifying the insulating tape used in shipping, and new fixtures.
P110043/S006
5/13/14
Omnilink Elite® Vascular Stent Systems Abbott Vascular
Temecula, CA 92591
Addition of receiving inspection and testing activities of raw materials and supply items at the Clonmel, Ireland facility and contract laboratories.
P120002/S003
5/12/14
SMART Control Vascular Stent Systems Cordis Corporation
Fremont, CA
94555
Change in manufacturing facility for the supplier of the slider assembly and handle and the introduction of a new molding machine.
P120005/S017
5/2/14
Dexcom G4 PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Change for the method of measurement of critical dimensions during receiving inspection of the Dexcom G4 PLATINUM transmitter tray, and the use of a food grade silicone spray during manufacturing of the transmitter tray.
P120010/S020
5/8/14
MiniMed 530G System Medtronic MiniMed
Northridge, CA 91325
Change to the laser cutting program parameters of the Resonetics Galvo Laser System.
P120010/S022
5/14/14
MiniMed 530G System Medtronic MiniMed
Northridge, CA 91325
Addition of an automated cleaning system for components used in the Enlite Sensor, which is a component of the MiniMed 530G System.
P130006/S003
5/28/14
VIABAHN Endoprosthesis W.L. Gore & Associates, Inc.
Phoenix, AZ
85085
New supplier for biological indicators.

Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 101   

Summary of PMA Originals Under Review
Total Under Review: 51   
Total Active: 26  
Total On Hold: 25  

Summary of PMA Supplements Under Review
Total Under Review: 513   
Total Active: 373   
Total On Hold: 140   

Summary of All PMA Submissions Received
Originals: 3
Supplements: 78  

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 101  
Number of Denials: 0   
Average Days Fr Receipt to Decision (Total Time): 131.9  
FDA Time: 103.2  Days    MFR Time: 28.7  Days

Page Last Updated: 01/26/2016
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