Medical Devices

March 2015 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
P110024
3/6/15
 
ResQCPR System
 
Advanced Circulatory Systems, Inc.
Roseville, MN 55113
 
Approval for the ResQCPR System. This device is indicated for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest.
 
P130013
3/13/15
 
WATCHMAN LAA Closure Technology
 
Boston Scientific Corporation
St. Paul, MN
55311
 
Approval for the WATCHMAN LAA Closure Technology.  This device is indicated to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation who: 1) Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2- VASc scores and are recommended for anticoagulation therapy; 2) Are deemed by their physicians to be suitable for warfarin; and 3) Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.
 
P130014
3/30/15
 
Adherus® AutoSpray Dural Sealant
 
HyperBranch Medical Technology, Inc.
Durham, NC
27713
 
Approval for the Adherus AutoSpray Dural Sealant. This device is indicated for use in patients who are 13 years of age and older, as an adjunct to standard methods of dural repair, such as when using sutures, to provide watertight closure during cranial procedures.
 
P140003
3/23/15
 
Impella 2.5 System
 
Abiomed, Inc.
Danvers, MA
01923
 
Approval for the Impella. This device is indicated for: The Impella 2.5 System is a temporary (≤ 6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
 

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P830055/S155
3/25/15
Special
 
LCS® Total Knee System
 
Depuy Orthopaedics, Inc.
Warsaw, IN
46581
 
Adding a manual check of the inlet RO water flow into Tank 7 to ensure that additional orders are not processed by the system when the flow rate is below the 3 gallon per minute requirement.
 
P850048/S040
3/20/15
135-Day
 
Access Hybritech PSA Assay
 
Beckman Coulter, Inc.
Chaska, MN
55318
 
Approval for the addition of an alternate vendor of the polypropylene resin used to manufacture the UniCel Dxl reaction vessels.
 
P860047/S029
3/3/15
Real-Time
 
OcuCoat® 2% Hydroxypropyl-
methylcellulose (HPMC) Solution
 
Bausch & Lomb Inc.
Irvine, CA
92688
 
Approval to replace the 25 gauge cannula that is packaged with the 1 mL OcuCoat product with a 23 gauge cannula.
 
P910073/S129
3/19/15
180-Day
 
ENDOTAK RELIANCE™ /S, ENDOTAK RELIANCE™ G/SG, ENDOTAK RELIANCE™ 4-SITE
 
Boston Scientific
St. Paul, MN
55112
 
Approval for changing from Oxyfume to 100% Ethylene Oxide sterilization and updated labeling.
 
P930014/S076
3/10/15
Real-Time
 
Acrysof® Aspheric UV Absorbing Intraocular Lens (IOL)
 
Alcon Laboratories, Inc.
Fort Worth, TX 76134
 
Approval for the AcrySof® Aspheric UV Absorbing Intraocular Lens (IOL) Model SA60WF. The device, as modified, will be marketed under the trade name AcrySof® Aspheric UV Absorbing Intraocular Lenses (IOLs) and is indicated for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag.
 
P930029/S047
3/5/15
Real-Time
 
Atakr Radiofrequency Catheter Ablation (RFCA) Systems
 
Medtronic, Inc.
Mounds View, MN 55112
 
Approval for revised specification, manufacturing inspection criteria and associated measurement fixture for the in-process inspection of the distal curve range of the RF Contactr ablation catheters.
 
P930029/S048
3/5/15
Real-Time
 
Atakr Radiofrequency Catheter Ablation (RFCA) Systems
 
Medtronic, Inc.
Mounds View, MN 55112
 
Approval for changes to labeling and packaging for specific accessories (i.e., cables and foot switch) used with the Medtronic Atakr RFCA Systems.
 
P950037/S142
3/19/15
180-Day
 
Entovis DR-T, Entovis DR, Entovis SR-T, Entovis SR, Eluna 8 DR-T ProMRI, Eluna 8
DR ProMRI, Eluna 8 SR-T ProMRI and Eluna 8 SR ProMRI Permanent Implantable
Pulse Generators, Setrox S 53, Setrox S 60, Safio S 53 and Safio S 60 Drug-Eluting Permanent Right Ventricular or Right Atrial Pacemaker Electrodes and
ICS 3000/Renamic Programmers (Software 1403.U)
 
Biotronik, INC.
6024 Jean Road
Lake Oswego, OR 97035
 
Approval for the removal of the scan location restrictions for the ProMRI pacemaker system as well as updates to the ICS 3000/ Renamic Programmer Software (1403.U) for the devices.
 
P950039/S026
3/2/15
180-Day
 
ThinPrep 5000 Processor
 
Hologic, Inc.
Marlborough, MA 01752
 
Approval for ThinPrep 5000 Processor.
 
P970003/S176
3/4/15
Real-Time
 
VNS Therapy System
 
Cyberonics, Inc.
Houston, TX
77058
 
Approval for an update to the longevity manufacturing requirement associated with the Model 102/102R and Model 105 Generators.
 
P970038/S029
3/20/15
135-Day
 
Access Hybritech Free PSA Reagent/ Calibrator Kit
 
Beckman Coulter, Inc.
Chaska, MN
55318
 
Approval for the addition of an alternate vendor of the polypropylene resin used to manufacture the UniCel Dxl reaction vessels.
 
P970053/S015
3/30/15
180-Day
 
Nidek EC-5000 Excimer Laser
 
Nidek Co., Ltd.
Gamagori, Aichi
Japan
443-0038
 
Approval for the a new 1 kHz eyetracker, which replaces the original 200 Hz eyetracker used with the EC-5000 Excimer Laser. This change also includes modification to the associated camera and software as well as the Infrared Red (IR) illumination. This device is indicated for topography-assisted laser- assisted in-situ keratomileusis (lasik) treatment using the final fit™ custom ablation treatment planning software for the reduction or elimination of myopic refractive errors from -1.0 to - 4.0 D of sphere with astigmatic refractive errors from ≥-0.5 to -2.0 D at the spectacle plane; in patients 21 years of age or older; and, in patients with documented stability of manifest refraction over the prior year, demonstrated by a change in MRSE not greater than ±0.5 D.
 
P980016/S521
3/30/15
180-Day
 
Maximo II ICD, Protecta ICD,
Protecta XT ICD,
Secura ICD,
Virtuoso II DR/VR ICD
 
Medtronic Inc.
Mounds View, MN 55112
 
Approval for the D453 IC to be used in the devices.
 
P980035/S374
3/19/15
180-Day
 
Advisa SR MRI SureScan, Advisa SR MRI and Advisa DR MRI Software Application Model 9995 Update
 
Medtronic, Inc.
Mounds View, MN 55112
 
Approval for the Advisa SR MRI A3SR01 Implantable Pulse Generator in combination with the CapSureFix MRI SureScan Lead Model 5086MRI to be marketed as the Advisa SR MRI SureScan. In addition, you requested approval for modifications to the Advisa SR MRI and Advisa DR MRI Software Application Model 9995.
 
P980037/S045
3/31/15
Real-Time
 
AngioJet® Rheolytic™ Thrombectomy System
 
Boston Scientific Corporation
Minneapolis, MN 55433
 
Approval for the addition of an inrush current limiter to the AngioJet Ultra Console.
 
P980040/S056
3/17/15
180-Day
 
TECNIS® Toric 1-Piece Intraocular Lens (IOL) with the TECNIS iTec Preloaded Delivery System
 
Abbott Medical Optics, Inc
Santa Ana, CA 92705
 
Approval for a change to the packaging of the Model Series ZCT Intraocular Lenses (IOL) from a wheelcase configuration to a preloaded packaging configuration/ delivery system. The preloaded lens models will be branded under the name “TECNIS® Toric 1-Piece IOL with TECNIS iTec Preloaded Delivery System, Models PCT150, PCT225, PCT300 and PCT400.”
 
P980041/S030
3/20/15
135-Day
 
Access AFP Immunoassay System
 
Beckman Coulter, Inc.
Chaska, MN
55318
 
Approval for the addition of an alternate vendor of the polypropylene resin used to manufacture the UniCel Dxl reaction vessels.
 
P980044/S024
3/31/15
180-Day
 
SUPARTZ®
 
Seikagaku Corporation
Tokyo, Japan
100-0005
 
Approval for revisions of the Instructions for Use (IFU) and the Patient Information (PI) for SUPARTZ as follows: 1) Revision in the instructions for use (IFU) and patient information (PI) of the statement, “The safety and effectiveness of repeat treatment cycles of SUPARTZ have not been established.” to “The effectiveness of repeat treatment cycles of SUPARTZ has not been established.”; and  2) Insertion in the IFU and PI of the statements, “Adverse experience data from the literature contain no evidence of increased safety risk relating to retreatment with SUPARTZ. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle.”
 
P990040/S020
3/24/15
Real-Time
 
TruFill N-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
 
Codman & Shurtleff, Inc.
Raynham, MA
02767
 
Approval for changing the supplier and the material for the n-Butyl Cyanoacrylate (n-BCA) caps.
 
P990074/S031
3/13/15
180-Day
 
Natrelle Saline-Filled Breast Implants
 
Allergan Incorporated
Goleta, CA
93117
 
Approval for the following packaging and manufacturing changes: 1) Modification of the primary inner and outer tray packaging to include two finger tabs; 2) Modification of the outer tray to include two cavities; 3) A change of the polycarbonate tray material to GEOX Peerex® 51 PC polycarbonate film to be supplied by Prent Thermoforming; 4) Primary lid packaging that is larger with blue ink arrows; 5) Larger secondary packaging boxes to house the larger trays; 6) A change to a separate tamper evident label, i.e., the product labels no longer serve as a tamper evident label; and 7) Changes to the heat sealing process (new parameters: temperature = 236-256oF, dwell time = 4.9-6.9 s, pressure = 60-80 psi).
 
P000009/S060
3/19/15
180-Day
 
BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S
 
Biotronik, INC.
6024 Jean Road
Lake Oswego, OR 97035
 
Approval for the removal of the scan location restrictions for the ProMRI pacemaker system as well as updates to the ICS 3000/ Renamic Programmer Software (1403.U) for the devices.
 
P000025/S081
3/11/15
Real-Time
 
MED-EL COMBI 40+ Cochlear Implant System
 
MED-EL Corporation
Durham, NC
27713
 
Approval for the DL-Coil, an external audio processor coil for use with the MED-EL cochlear implant, as part of the COMBI 40+ Cochlear Implant System.
 
P010012/S383
3/19/15
180-Day
 
ACUITY SPIRAL LEADS
 
Boston Scientific
St. Paul, MN
55112
 
Approval for changing from Oxyfume to 100% Ethylene Oxide sterilization and updated labeling.
 
P010021/S025
3/11/15
135-Day
 
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and VITROS Immunodiagnostic Products Anti-HCV Calibrator
 
Ortho-Clinical Diagnostics, Incorporated
Rochester, NY 14626
 
Approval for changes to the QC testing for the raw material anti-HCV positive plasma.
 
P010031/S485
3/30/15
180-Day
 
Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D
 
Medtronic Inc.
Mounds View, MN 55112
 
Approval for the D453 IC to be used in the devices.
 
P010032/S090
3/4/15
Real-Time
 
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM
 
St. Jude Medical
Plano, TX
75024
 
Approval for a design change to the stylet models that are used with SJM SCS systems; specifically, coating the stylets with a PFOA-free PTFE, resulting in Generation 3 of the stylets. This supplement also requested approval for a manufacturing change to tighten the tolerances on the tooling mandrel used to manufacture the associated lead models.
 
P010032/S094
3/24/15
Real-Time
 
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM
 
St. Jude Medical
Plano, TX
75024
 
Approval for minor design changes to the 8-Channel Adapter (Models 2311 and 2316) to introduce a new 8-Channel Adapter (Models 2321 and 2326) for the Spinal Cord Stimulation System.  The new 8-Channel Adapter is intended to connect a compatible 8-channel Boston Scientific lead or extension to a compatible St. Jude Medical implantable pulse generator.
 
P010047/S037
3/16/15
180-Day
 
ProGel Pleural Air Leak Surgical Sealant and ProGel Extended Applicatory Spray Tip
 
Neomend, Inc.
60 Technology Drive
Irvine, CA
92618
 
Approval to extend enrollment by 13 months to complete enrollment in the PAS to the post-approval study protocol.
 
P020050/S020
3/31/15
Real-Time
 
Wavelight Ex500 Excimer Laser System
 
Alcon Laboratories, Inc.
Fort Worth, TX 76134
 
Approval for a firmware fix.
 
P020056/S018
3/5/15
180-Day
 
Natrelle Silicone-Filled Brest Implants
 
Allergan Incorporated
Irvine, CA
92612
 
Approval for updated labeling to include 10 year data from the Core Clinical Study.
 
P020056/S027
3/13/15
180-Day
 
Natrelle Silicone-Filled Breast Implants
 
Allergan Incorporated
Goleta, CA
93117
 
Approval for the following packaging and manufacturing changes: 1) Modification of the primary inner and outer tray packaging to include two finger tabs; 2) Modification of the outer tray to include two cavities; 3) A change of the polycarbonate tray material to GEOX Peerex® 51 PC polycarbonate film to be supplied by Prent Thermoforming; 4) Primary lid packaging that is larger with blue ink arrows; 5) Larger secondary packaging boxes to house the larger trays; 6) A change to a separate tamper evident label, i.e., the product labels no longer serve as a tamper evident label; and 7) Changes to the heat sealing process (new parameters: temperature = 236-256oF, dwell time = 4.9-6.9 s, pressure = 60-80 psi).
 
P030008/S018
3/31/15
Real-Time
 
Wavelight Ex500 Excimer Laser System
 
Alcon Laboratories, Inc.
Fort Worth, TX 76134
 
Approval for a firmware fix.
 
P030017/S206
3/31/15
 
Precision Spectra Spinal Cord Stimulator (SCS) System
 
Boston Scientific Corporation
Valencia, CA
91355
 
Adding an alternate qualified supplier for the grooved Coil Connector that is used in the assembly of the Precision Spectra Implantable Pulse Generator (IPG).
 
P030031/S065
3/18/15
180-Day
 
ThermoCool Catheters For the Treatment of Type I Atrial Flutter and Atrial Fibrillation
 
Biosense Webster, Inc.
Diamond Bar, CA 91765
 
Approval for modification of the ThermoCool SmartTouch shaft and sensor.
 
P030056/S008
3/10/15
180-Day
 
ADVIA Centaur® HCV ReadyPack Reagents, ADVIA Centaur® HCV Quality Control Materials
 
Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY 10591
 
Approval for the claim to test a pediatric population with the FDA approved ADVIA Centaur HCV ReadyPack Reagents and ADVIA Centaur HCV Quality Control Materials. The device, as modified, will be marketed under the trade name ADVIA Centaur HCV ReadyPack Reagents and ADVIA Centaur HCV Quality Control Materials and is indicated for: ADVIA Centaur and ADVIA Centaur XP systems.  The ADVIA Centaur HCV (aHCV) assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin G (IgG) antibodies to hepatitis C virus (HCV) in human pediatric (18 months – 21 years) and adult serum and plasma (EDTA, lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP systems. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection. ADVIA Centaur CP system:  The ADVIA Centaur HCV (aHCV) assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin G (IgG) antibodies to hepatitis C virus (HCV) in human pediatric (18 months – 21 years) and adult serum and plasma (EDTA, lithium or sodium heparinized) using the ADVIA Centaur CP system. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection.
 
P040013/S020
3/9/15
Special
 
Gems 21s (Growth-Factor Enhanced Matrix)
 
Luitpold Pharmaceuticals, Inc.
Norristown, PA
19403
 
Approval for final patient labeling.
 
P040036/S048
3/18/15
180-Day
 
ThermoCool Catheters For the Treatment of Ventricular Tachycardia
 
Biosense Webster, Inc.
Diamond Bar, CA 91765
 
Approval for modification of the ThermoCool SmartTouch shaft and sensor.
 
P040044/S062
3/3/15
Real-Time
 
Mynx Ace Vascular Closure Device (Mynx Ace)
 
Access Closure, Inc.
Santa Clara, CA 95054
 
Approval for minor modifications to the Mynx Ace device that involve Button 3, the packaging tray, and Instructions for Use (IFU) associated with Button 3.
 
P040046/S009
3/13/15
180-Day
 
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast
Implants
 
Allergan Incorporated
Goleta, CA
93117
 
Approval for the following packaging and manufacturing changes: 1) Modification of the primary inner and outer tray packaging to include two finger tabs; 2) Modification of the outer tray to include two cavities; 3) A change of the polycarbonate tray material to GEOX Peerex® 51 PC polycarbonate film to be supplied by Prent Thermoforming; 4) Primary lid packaging that is larger with blue ink arrows; 5) Larger secondary packaging boxes to house the larger trays; 6) A change to a separate tamper evident label, i.e., the product labels no longer serve as a tamper evident label; and 7) Changes to the heat sealing process (new parameters: temperature = 236-256oF, dwell time = 4.9-6.9 s, pressure = 60-80 psi).
 
P050023/S081
3/19/15
180-Day
 
ICS 3000/Renamic Programmers (Software 1403.U)
 
Biotronik, INC.
6024 Jean Road
Lake Oswego, OR 97035 
 
Approval for the removal of the scan location restrictions for the ProMRI pacemaker system as well as updates to the ICS 3000/ Renamic Programmer Software (1403.U) for the devices.
 
P050038/S023
3/16/15
180-Day
 
ARISTA AH FlexiTip XL-R for Arista AH, Absorbable Hemostatic Particles
 
C. R. Bard Incorporated
Woburn, MA
01801
 
Approval for the line extension of the FLEXITIP XL Applicator Family to include the FLEXITIP XL-R applicator. The modification is based upon the current applicator design but now includes an additional outer stainless steel tubing to create a rigid (XL-R) portion of the applicator tip. In addition, approval for revision of the instructions for use of the ARISTA AH product labeling in order to inform users of use of the new applicator during endoscopic/ laparoscopic uses.
 
P060028/S005
3/2/15
180-Day
 
MemoryShape™ Breast Implants
 
Mentor Worldwide, LLC
Santa Barbara, CA 93111
 
Approval for a change to a “low bleed” patch design for MemoryShape Breast Implants.
 
P060037/S032
3/10/15
135-Day
 
NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee
 
Zimmer, Inc.
Warsaw, IN
46581
 
Approval for a change in water quality monitoring.
 
P060039/S065
3/11/15
135-Day
 
Attain StarFix Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Approval an update to the manufacturing process of the blue tubing used in the construction of the lead to replace Tygon with Viton.
 
P070008/S057
3/19/15
180-day
 
ICS 3000/Renamic Programmers (Software 1403.U)
 
Biotronik, INC.
6024 Jean Road
Lake Oswego, OR 97035 
 
Approval for the removal of the scan location restrictions for the ProMRI pacemaker system as well as updates to the ICS 3000/ Renamic Programmer Software (1403.U) for the devices.
 
P070026/S024
3/18/15
180-Day
 
Ceramax Ceramic Hip System
 
Depuy, Inc.
Warsaw, IN
46581
 
Approval for the for the inclusion of the SUMMIT® POROCOAT® femoral prosthesis, the PINNACLE® 300 Series, Multi-Hole and Sector II acetabular shells and the Tamp Extractor manual surgical instrument for the newly enrolled patients study arm to the post-approval study protocol.
 
P070026/S025
3/10/15
180-Day
 
Depuy Ceramax Ceramic Total Hip System
 
Depuy, Inc.
Warsaw, IN
46581
 
Approval of the following changes to the post-approval study for the device: patients with any of 5 different stems to participate to facilitate patient enrollment and removing acetabular shells from this PAS protocol.
 
P070026/S026
3/12/15
180-Day
 
Depuy Ceramax Ceramic Total Hip System
 
Depuy, Inc.
Warsaw, IN
46581
 
Approval of the post-approval study protocol.
 
P070026/S029
3/25/15
Special
 
Ceramax® Ceramic Total Hip System
 
Depuy Orthopaedics, Inc.
Warsaw, IN
46581
 
Adding a manual check of the inlet RO water flow into Tank 7 to ensure that additional orders are not processed by the system when the flow rate is below the 3 gallon per minute requirement.
 
P080009/S004
3/23/15
180-Day
 
Sedasys Computer‐Assisted Personalized Sedation System
 
Ethicon Endo-Surgery, Inc.
Cincinnati, OH 45242
 
Approval of the changes to the post-approval study protocol.
 
P080009/S005
3/25/15
180-Day
 
SEDASYS Computer-Assisted Personalized Sedation System
 
Ethicon Endo-Surgery, Inc.
Cincinnati, OH 45242
 
Approval of the changes to the post-approval study protocol.
 
P080011/S035
3/11/15
180-Day
 
Biofinity Energys Asphere, Biofinity XR Toric, and Biofinity XR Multifocal
(comfilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear
 
CooperVision, Inc.
Pleasanton CA 94588
 
Approval for a change in trade name for the Biofinity Energys Aspheric Lens and expanded powers for the Biofinity XR Toric and Biofinity XR Multifocal Lenses. The devices, as modified, will be marketed under the trade names Biofinity Energys Asphere, Biofinity XR Toric, and Biofinity XR Multifocal (comfilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear and are indicated for: BIOFINITY Energys™ Asphere (comfilcon A) soft contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. BIOFINITY XR TORIC (comfilcon A) Soft Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 D and astigmatism corrections from -0.25 to -5.75 D. BIOFINITY XR MULTIFOCAL (comfilcon A) lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) with emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 D and with add powers from +0.05 to +4.00 D. The lenses may be worn by persons who exhibit astigmatism of 2.00 D or less that does not interfere with visual acuity. The BIOFINITY (comfilcon A) Soft (hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights and 7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of exteneded wear can be followed as determined by teh prescribing eye care professional. Eye care practitioners may prescribe the lens for frequent replacement wear, with cleaning, disinfecting, and scheduled replacements.
 
P080030/S014
3/24/15
Real-Time
 
Glaukos iStent® Trabecular Micro-Bypass Stent System
 
Glaukos® Corporation
Laguna Hills, CA 92653
 
Approval to update the magnetic resonance imaging (MRI) information in the Instruction for Use and patient ID card of the iStent Trabecular Micro-Bypass Stent System.
 
P090026/S014
3/20/15
135-Day
 
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
 
Beckman Coulter, Inc.
Chaska, MN
55318
 
Approval for the addition of an alternate vendor of the polypropylene resin used to manufacture the UniCel Dxl reaction vessels.
 
P100005/S005
3/2/15
180-Day
 
M-Vu Algorithm Engine
 
VuCOMP, Inc.
Plano, TX
75093
 
Approval for M-Vu Algorithm Engine version 3.2.0.0.
 
P100021/S045
3/25/15
Special
 
Endurant Stent Graft System, Endurant (II/IIs) Stent Graft System, Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System
 
Medtronic Vascular
Santa Rosa, CA 95403
 
Approval for the addition of a manufacturing aid to be used during the thumbwheel assembly process.
 
P100025/S008
3/5/15
180-Day
 
BreathTek® UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation
 
Otsuka America Pharmaceutical, Incorporated
Rockville, MD 20850
 
Approval for an amendment to the Drug Master File for the following changes:  1) Additional process development work for the purification process; 2) Validation of the purification process improvements; 3) Site transfer for the purification process; 4) Change to a specification of a starting material; 5. Additional sizes for the outer container and inner bags for the purification process; and 6) Updated stability information.
 
P100026/S026
3/10/15
Real-Time
 
Neuropace RNS® System
 
Neuropace, Inc
Mountain View, CA
94043
 
Approval for a modification to the battery assembly to add additional carbon monoflouride (CFx) cathode material.
 
P100034/S011
3/17/15
135-Day
 
NovoTTF-100A System
 
Novocure Ltd.
Haifa, Israel
31905
 
Approval for an alternate source of shrink coverage material used in the INE insulated transducer arrays
 
P100034/S012
3/23/15
135-Day
 
NovoTTF-lOOA System
 
Novocure Ltd.
Haifa, Israel
31905
 
Approval for an additional supplier of 15V DC/DC Converter Component for Novo TTF-100A System
 
P100047/S055
3/25/15
Special
 
HeartWare® Ventricular Assist System
 
HeartWare, Inc.
Miami Lakes, FL 33014
 
Approval for an additional independent inspection at final packaging.
 
P110004/S011
3/17/15
Special
 
NIRxcell CoCr Coronary Stent On Rx
 
Medinol, Ltd.
Tel Aviv, Israel 6158101
 
Approval for a patient implant card.
 
P110037/S016
3/26/15
Real-Time
 
COBAS® AmpliPrep/
COBAS® TaqMan® CMV Test
 
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
 
Approval for software changes to the Total Aspiration and Dispense Monitoring (TADM) Tolerance Band Parameters for the cobas p 630 instrument for pipetting CAP/CTM CMV Controls.
 
P110038/S009
3/6/15
180-Day
 
Relay Thoracic Stent-Graft with Plus Delivery System
 
Bolton Medical, Inc.
Sunrise, FL
33325
 
Approval to increase the rate of enrollment to a more acceptable rate in the post-approval study protocol.
 
P110042/S043
3/13/15
180-Day
 
EMBLEM S-ICD System
 
Boston Scientific Corporation
St Paul, MN
55112
 
Approval for the EMBLEM S-ICD System.
 
P120010/S056
3/20/15
Real-Time
 
Minimed 530g System
 
Medtronic Minimed
Northridge, CA 91325
 
Approval for additional manufacturing testing to be performed on a different version of a component used in the manufacture of the MiniMed 530G Insulin Pump MMT-551, MMT-751 that is part of the MiniMed 530G System.
 
P130005/S006
3/18/15
Real-Time
 
Diamondback 360 Coronary Orbital Atherectomy System (OAS)
 
Cardiovascular Systems, Inc.
St. Paul, MN
55112
 
Approval for a change in the design of the flexible container system of the ViperSlide (lntralipid 10%) lubricant.
 
P130021/S010
3/30/15
Panel-Track
 
Medtronic CoreValve™ System (MCS),Trans-catheter Aortic Valve (TAV),
CoreValve™ Evolut™, Delivery Catheter System (DCS), and Compression Loading System
 
Medtronic CoreValve LLC
Santa Rosa, CA 95403
 
Approval for the Medtronic CoreValve™ system. This device is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥ 8% or at a ≥15% risk of mortality at 30 days).
 
P130026/S002
3/26/15
Special
 
TactiCath Quartz Set
 
St. Jude Medical
St. Paul, MN
55117
 
Approval for changes to the manufacturing process and an additional inspection associated with irrigation tubing.
 

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
P810002/S095
3/26/15
 
SJM Mechanical Heart Valves
 
St. Jude Medical, Inc.
St. Paul, MN
55117
 
New method for leaflet substrate slicing.
 
P810006/S059
3/20/15
 
CollaStat Absorbable Collagen Hemostatic Sponge,
CollaStat Absorbable Collagen Hemostatic Agent-Microfibrillar Form
 
Integra LifeSciences Corporation
Plainsboro, NJ 08536
 
Addition of a new ethanol squeeze device to replace the hand squeezing process currently used during manufacture of the devices.
 
P810006/S060
3/26/15
 
Collastat Absorbable Collagen Hemostatic Sponge,
Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form
 
Integra LifeSciences Corporation
Plainsboro, NJ 08536
 
Enhanced compressor configuration.
 
P830061/S118
3/2/15
 
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Addition of a new shrink wrap machine to the final packaging line.
 
P840001/S293
3/6/15
 
Spinal Cord Stimulation System
 
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
 
Automate inspection of final device sealed tray package.
 
P840001/S294
3/20/15
 
RESTORE, ITREL  AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEAD
 
Medtronic Inc.
Neuromodulation
Minneapolis, MN 55432
 
Change the braided lead body cutting process.
 
P840001/S295
3/27/15
 
Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems and
Pisces, Specify and Vectris SCS Leads
 
Medtronic Inc.
Neuromodulation
Minneapolis, MN
55432
 
Transfer of incoming inspection activities for a number of components.
 
P840062/S044
3/26/15
 
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound
Dressings for Dental Surgery
 
Integra LifeSciences Corporation
Plainsboro, NJ 08536
 
Enhanced compressor configuration.
 
P850010/S058
3/20/15
 
HeliStat, Helitene Absorbable Collagen Hemostatic Agents
 
Integra LifeSciences Corporation
Plainsboro, NJ 08536
 
Addition of a new ethanol squeeze device to replace the hand squeezing process currently used during manufacture of the devices.
 
P850010/S059
3/26/15
 
Helistat, Helitene Absorbable Collagen Hemostatic Agents
 
Integra LifeSciences Corporation
Plainsboro, NJ 08536
 
Enhanced compressor configuration.
 
P850064/S029
3/20/15
 
Life Pulse High Frequency Ventilator
 
Bunnell, Inc.
Salt Lake City, UT
84115
 
Addition of an automated wire stripper.
 
P850089/S113
3/2/15
 
CapSure SP Novus Lead, CapSure Z Novus Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Addition of a new shrink wrap machine to the final packaging line.
 
P860003/S078
3/19/15
 
Therakos UVAR XTS and CELLEX Photopheresis Systems
 
Therakos Inc.
Bridgewater, NJ 08807
 
Manufacturing process change for a component of the Therakos CELLEX Photopheresis Systems.
 
P860004/S221
3/2/15
 
Medtronic SynchroMed Infusion System
 
Medtronic, Incorporated
Neuromodulation
Minneapolis, MN, 55432
 
Relocation of an external supplier’s manufacturing facility and the replacement of the current laser marking equipment.
 
P860004/S222
3/3/15
 
Medtronic SynchroMed Infusion System
 
Medtronic, Incorporated
Neuromodulation
Minneapolis, MN, 55432
 
Update the cleaning process of the pump head components.
 
P860004/S223
3/27/15
 
SynchroMed Infusion System
 
Medtronic Inc.
Neuromodulation
Minneapolis, MN
55432
 
Transfer of incoming inspection activities for a number of components.
 
P890003/S327
3/2/15
 
CapSure VDD 2 Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Addition of a new shrink wrap machine to the final packaging line.
 
P900033/S043
3/4/15
 
Integra Dermal Regeneration Template
 
Integra LifeSciences Corporation
Plainsboro, NJ 08536
 
Qualification of a new product package sealing equipment for the Integra Dermal Regeneration Template, at the Plainsboro, New Jersey, Integra manufacturing facility.
 
P910007/S048
3/26/15
 
ARCHITECT Total PSA
 
Abbott Laboratories
Park, IL
60064
 
Changes in the precursor code for bovine serum and human prostate specific antigen with equivalent materials for the manufacture of the ARCHITECT Free PSA and Total PSA Calibrators, Controls, and Secondary Calibrators.
 
P920015/S148
3/3/15
 
Sprint Quattro Lead
 
Medtronic Incorporated
Mounds View, MN 55112
 
Implement a new method to apply adhesive to slits in the models.
 
P920015/S149
3/2/15
 
Sprint Quattro Lead, Subcutaneous Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Addition of a new shrink wrap machine to the final packaging line.
 
P920047/S077
3/24/15
 
Blazer II, Blazer II HTD, Blazer Prime HTD Ablation Catheters
 
Boston Scientific Corporation
St. Paul, MN
55112
 
New traceability and tracking system at the Heredia, Costa Rica location.
 
P930014/S078
3/19/15
 
AcrySof® Intraocular
 
Alcon Research, Ltd.
Fort Worth, TX 76134
 
Two alternate polypropylene resins, Basell PD702 and Total M3766.
 
P930038/S075
3/26/15
 
Angio-Seal™ Vascular Closure Device
 
St. Jude Medical
Plymouth, MN 55442
 
Alternate dose audit sterility testing vendor.
 
P930039/S125
3/2/15
 
CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, Vitatron Crystalline Active Fixation Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Addition of a new shrink wrap machine to the final packaging line.
 
P930039/S126
3/11/15
 
CapSureFix Novus Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Updates to procedures for torque testing at final functional inspection.
 
P950005/S056
3/19/15
 
EZ Steer DS, Celsius Catheters
 
Biosense Webster, Inc.
Diamond Bar, CA 91765
 
Additional qualified supplier for extrusion and braiding processes.
 
P950029/S103
3/17/15
 
Reply SR, Reply DR, Esprit SR, Esprit DR
 
Sorin CRM USA, Inc.
Arvada, CO
80004
 
Addition of Automated Optical Inspection (AOI) in manufacturing assembly line for the devices.
 
P950029/S104
3/19/15
 
Reply SR, Reply DR, Esprit SR, Esprit DR
 
Sorin CRM USA, Inc.
Arvada, CO
80004
 
Add an alternate supplier for the glue used in the die attach process for the hybrids used in the devices.
 
P960009/S217
3/6/15
 
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
 
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
 
Automate inspection of final device sealed tray package.
 
P960009/S218
3/20/15
 
Activa Deep Brain Stimulation Therapy System; DBS Leads
 
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
 
Addition of an alternate material and component supplier.
 
P960009/S221
3/27/15
 
Activa Deep Brain Stimulation (DBS) Therapy System
 
Medtronic Inc.
Neuromodulation
Minneapolis, MN
55432
 
Transfer of incoming inspection activities for a number of components.
 
P960040/S343
3/1/15
 
INOGEN ICD,  ORIGEN ICD, DYNAGEN ICD
 
Boston Scientific Corporation
St. Paul, MN
55112
 
Alternate supplier of the HV capacitor lids for the devices.
 
N970003/S171
3/23/15
 
ADVANTIO™ Pacemaker;  INGENIO™ Pacemaker; VITALIO™ Pacemaker
 
Boston Scientific Corporation
St. Paul, MN 55112
 
Manufacture the battery feedthru subassembly used in the devices at the St. Paul facility.
 
N970003/S172
3/27/15
 
ADVANTIO, INGENIO, VITALIO, FORMIO
 
Boston Scientific
St. Paul, MN
55112
 
Addition of a deburring operation and additional monitoring during the manufacturing of case halves for the devices.
 
P970004/S190
3/6/15
 
INTERSTIM THERAPY SYSTEM
 
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
 
Automate inspection of final device sealed tray package.
 
P970004/S192
3/26/15
 
Sacral Nerve Stimulation (SNS), Urinary Implantable Neurostimulator (INS) Interstim Family
 
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
 
Manufacturing change affecting the component of an implantable neurostimulator (INS) used for the Medtronic Neuromodulation Sacral Nerve Stimulation (SNS) therapies.
 
P970004/S193
3/27/15
 
InterStim Therapy System
 
Medtronic Inc.
Neuromodulation
Minneapolis, MN
55432
 
Transfer of incoming inspection activities for a number of components.
 
P970051/S128
3/13/15
 
Cochlear Nucleus CI24RE Cochlear Implant, Cochlear Nucleus CI422
Cochlear Implant
 
Cochlear Americas
Centennial, CO 80111
 
Addition of the helium bombing, and removal of gross leak test for the Magnet Assembly.
 
P980003/S057
3/24/15
 
Chilli II Cooled Ablation System
 
Boston Scientific Corporation
St. Paul, MN
55112
 
New traceability and tracking system at the Heredia, Costa Rica location.
 
P980006/S024
3/23/15
 
PureVision® Toric® and PureVision2® Toric Product Family
 
Bausch & Lomb
Rochester, NY 14609
 
New optical comparator vision system.
 
P980007/S039
3/26/15
 
ARCHITECT Free PSA
 
Abbott Laboratories
Park, IL
60064
 
Changes in the precursor code for bovine serum and human prostate specific antigen with equivalent materials for the manufacture of the ARCHITECT Free PSA and Total PSA Calibrators, Controls, and Secondary Calibrators.
 
P980016/S526
3/4/15
 
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
 
Add alternative ultraviolet (UV) irradiator equipment in the manufacturing process for the devices.
 
P980016/S527
3/1/15
 
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 Incorporated
Mounds View, MN 55112
 
Update the final visual inspection criteria for the hybrids used in the  devices.
 
P980016//S528
3/3/15
 
Evera S, Evera XT, Maximo, Protecta, Protecta XT, Secura, and Virtuoso II ICDs
 
Medtronic Inc.
Mounds View, MN 55112
 
Updates to the integrated circuit test software and test process.
 
P980016/S530
3/1/15
 
Brava, Brava Quad,
Viva S, Viva XT,
Viva Quad S, and
Viva Quad XT CRT-Ds
 
Medtronic, Inc.
Mounds View, MN 55112
 
Connector module inspection updates including the addition of inspection criteria specific to embedded fibers and the addition of a redundant inspection step verifying the presence of a radiopaque.
 
P980016/S531
3/17/15
 
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD
 
Medtronic Inc.
Mounds View, MN 55112
 
Changes to the capacitor manufacturing line.
 
P980016/S532
3/11/15
 
Evera S DR, Evera S VR, Evera XT DR, and Evera XT VR ICDs
 
Medtronic, Inc.
Mounds View, MN 55112
 
Add new equipment for the Fill Hole Seal (FHS) and Button (BTN) welds which are used to hermetically seal the electrolyte fill port.
 
P980016/S533
3/17/15
 
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD
 
Medtronic, Inc.
Mounds View, MN 55112
 
Update to the manufacturing process for the capacitor case subassembly used in the devices.
 
P980016/S534
3/19/15
 
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD
 
Medtronic, Inc.
Mounds View, MN 55112
 
Merging two different electrical connector monitoring plans to establish one standard plan used for both the battery and capacitor electrical connectors.
 
P980035/S411
3/4/15
 
Advisa DR IPG, Advisa DR MRI IPG , Relia IPG, Adapta, Versa, Sensia IPG
 
Medtronic, Inc.
Mounds View, MN 55112
 
Add alternative ultraviolet (UV) irradiator equipment in the manufacturing process for the devices.
 
P980035/S412
3/1/15
 
Advisa DR IPG, Advisa DR MRI IPG , Relia IPG, Adapta, Versa, Sensia IPG
 
Medtronic Incorporated
Mounds View, MN 55112
 
Update the final visual inspection criteria for the hybrids used in the  devices.
 
P980035/S413
3/3/15
 
Advisa DR, Advisa DR MRI IPGs
 
Medtronic Inc.
Mounds View, MN 55112
 
Updates to the integrated circuit test software and test process.
 
P980049/S106
3/17/15
 
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR, Intensia VR ICD,
Intensia DR
 
Sorin CRM USA, Inc.
Arvada, CO
80004
 
Addition of Automated Optical Inspection (AOI) in manufacturing assembly line for the devices.
 
P980049/S107
3/13/15
 
Paradym VR, Paradym DR,
Paradym RF VR, Paradym RF DR, Paradym RF VR, Paradym RF DR, Intensia VR, Intensia DR
 
Sorin CRM USA, Inc.
Arvada, CO
80004
 
Use of additional electrical welding equipment in the manufacturing laboratory.
 
P980049/S108
3/19/15
 
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR, Intensia VR, Intensia DR
 
Sorin CRM USA, Inc.
Arvada, CO
80004
 
Add an alternate supplier for the glue used in the die attach process for the hybrids used in the devices.
 
P980050/S098
3/2/15
 
Transvene CS/SVC Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Addition of a new shrink wrap machine to the final packaging line.
 
P990004/S026
3/17/15
 
SURGIFOAM Absorbable Gelatin Sponge, USP
 
Ethicon, Inc.
Somerville, NJ 08876
 
Changes to the sampling frequency used for the in-process visual inspection, barcode scanning and vacuum testing performed on the SURGIFOAM packaging.
 
P990004/S027
3/17/15
 
SURGIFOAM Absorbable Gelatin Sponge, USP
 
Ethicon, Inc.
Somerville, NJ 08876
 
Optimization of a pouch packaging machine used for the manufacture of SURGIFOAM Absorbable Gelatin Sponge.
 
P990025/S044
3/19/15
 
EZ Steer Nav, NaviStar Catheters
 
Biosense Webster, Inc.
Diamond Bar, CA 91765
 
Additional qualified supplier for extrusion and braiding processes.
 
P990025/S045
3/23/15
 
EZ Steer Nav, NaviStar Catheters
 
Biosense Webster, Inc.
Diamond Bar, CA 91765
 
Adding a second supplier for the 1mm sensor component used in the catheter families.
 
P000006/S041
3/4/15
 
Titan Inflatable Penile Prosthesis
 
Coloplast Corp
Minneapolis, MN 55411
 
Implementing use of an additional cavity in an existing multi cavity mold.
 
P000006/S042
3/5/15
 
Titan Inflatable Penile Prosthesis
 
Coloplast Corp
Minneapolis, MN 55411
 
Implementing a modified preparation procedure for tubing.
 
P000006/S043
3/5/15
 
Titan Inflatable Penile Prosthesis
 
Coloplast Corp
Minneapolis, MN 55411
 
Change to the Exhaust Core Diameter dimension on the Titan Touch Pump Body Drawing. The change involves updating the Titan Touch Pump Body Drawing to reflect the measurements obtained using a consistent cut technique.
 
P000037/S039
3/26/15
 
On-x Prosthetic Heart Valve
 
On-x Life Technologies, Inc.
Austin, TX
78752
 
Additional X-Ray Machine.
 
P010001/S011
3/25/15
 
Transcend Hip Articulation System
 
CeramTec GmbH
Plochingen, Germany
D-73207
 
Addition of cleaning equipment.
 
P010012/S385
3/1/15
 
INOGEN CRT-D, ORIGEN CRT-D,
DYNAGEN CRT-D
 
Boston Scientific Corporation
St. Paul, MN
55112
 
Alternate supplier of the HV capacitor lids for the devices.
 
P010013/S062
3/19/15
 
NovaSure Impedance Controlled Endometrial Ablation System
 
Hologic, Inc.
Marlborough, MA 01752
 
Addition of an in-house assembly process for the Radio Frequency Controller component.
 
P010015/S263
3/4/15
 
Consulta CRT-P, Syncra CRT-P, Viva CRT-P
 
Medtronic, Inc.
Mounds View, MN 55112
 
Add alternative ultraviolet (UV) irradiator equipment in the manufacturing process for the devices.
 
P010015/S264
3/1/15
 
Consulta CRT-P, Syncra CRT-P, Viva CRT-P
 
Medtronic Incorporated
Mounds View, MN 55112
 
Update the final visual inspection criteria for the hybrids used in the  devices.
 
P010015/S265
3/3/15
 
Consulta, Syncra, and Viva CRT-Ps
 
Medtronic Inc.
Mounds View, MN 55112
 
Updates to the integrated circuit test software and test process.
 
P010015/S267
3/2/15
 
Attain OTW Lead, Attain Bipolar OTW Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Addition of a new shrink wrap machine to the final packaging line.
 
P010029/S022
3/12/15
 
EUFLEXXA (1% Sodium Hyaluronate)
 
Ferring Pharmaceuticals, Inc.
Parsippany, NJ 07054
 
Proposed scale-up of manufacturing processes to increase product yield per lot for the EUFLEXXA product.
 
P010030/S060
3/27/15
 
ZOLL LifeVest WCD 4000
 
ZOLL Manufacturing Corporation
Pittsburgh, PA 15238
 
Expansion of an electrical test procedure to cover additional components, implementation of a new work instruction, and addition of an independent visual verification step.
 
P010031/S490
3/4/15
 
Brava CRT-D, Brava Quad CRT-D,
Concerto II CRT-D, Consulta CRT-D,
Maximo II CRT-D, Protecta CRT-D,
Protecta XT
CRT-D, Viva
Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT
CRT-D
 
Medtronic, Inc.
Mounds View, MN 55112
 
Add alternative ultraviolet (UV) irradiator equipment in the manufacturing process for the devices.
 
P010031/S491
3/1/15
 
Brava CRT-D, Brava Quad CRT-D,
Concerto II CRT-D, Consulta CRT-D,
Maximo II CRT-D, Protecta CRT-D,
Protecta XT
CRT-D, Viva
Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT
CRT-D
 
Medtronic Incorporated
Mounds View, MN 55112
 
Update the final visual inspection criteria for the hybrids used in the  devices.
 
P010031/S492
3/3/15
 
Brava, Brava Quad, Concerto, Consulta, Maximo, Protecta, Protecta XT, Viva Quad, Viva Quad, Viva S and Viva XT CRT-Ds
 
Medtronic Inc.
Mounds View, MN 55112
 
Updates to the integrated circuit test software and test process.
 
P010031/S493
3/1/15
 
Brava, Brava Quad,
Viva S, Viva XT,
Viva Quad S, and
Viva Quad XT CRT-Ds
 
Medtronic, Inc.
Mounds View, MN 55112
 
Connector module inspection updates.
 
P010031/S495
3/17/15
 
Brava CRT-D, Brava Quad CRT-D, Viva Quad S
CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D
 
Medtronic Inc.
Mounds View, MN 55112
 
Alternate manufacturing line for the triple assembly, Pin Trim, Capaciter Electrial connector placmentt, CEC Pin bend, laser condition, CEC Pin resistance spot weld CEC underfill and triple eval inspection: including incorportion automation for 2 process and modification Pin laser condition step.
 
P010031/S496
3/11/15
 
Brava, Brava Quad,
Viva S, Viva XT,
Viva Quad S, and
Viva Quad XT CRT-Ds
 
Medtronic, Inc.
Mounds View, MN 55112
 
Add new equipment for the Fill Hole Seal (FHS) and Button (BTN) welds which are used to hermetically seal the electrolyte fill port.
 
P010031/S497
3/17/15
 
Brava CRT-D, Brava Quad CRT-D, Viva Quad S
CRT-D, Viva Quad XT CRT-D. Viva S CRT-D, Viva XT CRT-D
 
Medtronic, Inc.
Mounds View, MN 55112
 
Update to the manufacturing process for the capacitor case subassembly used in the devices.
 
P010031/S498
3/19/15
 
Brava CRT-D,
Brava Quad CRT-D,
Viva Quad S
CRT-D, Viva Quad XT CRT-D, Viva S CRT-D,
Viva XT CRT-D
 
Medtronic, Inc.
Mounds View, MN 55112
 
Merging two different electrical connector monitoring plans to establish one standard plan used for both the battery and capacitor electrical connectors.
 
P010068/S045
3/19/15
 
EZ Steer Nav DS Catheters
 
Biosense Webster, Inc.
Diamond Bar, CA 91765
 
Additional qualified supplier for extrusion and braiding processes.
 
P010068/S046
3/23/15
 
EZ Steer NAV DS
 
Biosense Webster, Inc.
Diamond Bar, CA 91765
 
Adding a second supplier for the 1mm sensor component used in the catheter families.
 
P020004/S111
3/31/15
 
GORE® EXCLUDER® AAA Endoprosthesis
 
W.L. Gore and Associates
Flagstaff, AZ 860003
 
Use film materials manufactured by Gore’s approved supplier on an alternating manufacturing line for GORE TAG Endoprosthesis and the GORE EXCLUDER AAA Endoprosthesis.
 
P020025/S068
3/24/15
 
Blazer Prime XP, Blazer II XP, IntellaTip MiFi XP Ablation Catheters
 
Boston Scientific Corporation
St. Paul, MN
55112
 
New traceability and tracking system at the Heredia, Costa Rica location.
 
P030005/S117
3/23/15
 
INVIVE™ CRT-P; INTUA™ CRT-P
 
Boston Scientific Corporation
St. Paul, MN 55112
 
Manufacture the battery feedthru subassembly used in the devices at the St. Paul facility.
 
P030015/S118
3/27/15
 
INVIVE, INTUA
 
Boston Scientific
St. Paul, MN
55112
 
Addition of a deburring operation and additional monitoring during the manufacturing of case halves for the devices.
 
P030017/S214
3/13/15
 
Precision Spectra Spinal Cord Stimulator System
 
Boston Scientific Neuromodulation
Valencia, CA
91355
 
Upgrade to new battery test equipment.
 
P030017/S215
3/25/15
 
Precision and Precision Spectra Spinal Cord Stimulator (SCS) Systems
 
Boston Scientific Neuromodulation
Valencia, CA
91355
 
Add a supplier of printed circuit board components.
 
P030031/S066
3/19/15
 
EZ Steer, ThermoCool Catheters
 
Biosense Webster, Inc.
Diamond Bar, CA 91765
 
Additional qualified supplier for extrusion and braiding processes.
 
P030031/S067
3/23/15
 
EZ Steer ThermoCool NAV, ThermoCool SF NAV
 
Biosense Webster, Inc.
Diamond Bar, CA 91765
 
Adding a second supplier for the 1mm sensor component used in the catheter families.
 
P030036/S077
3/2/15
 
SelectSecure Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Addition of a new shrink wrap machine to the final packaging line.
 
P030053/S024
3/17/15
 
Mentor MEMORYGEL Silicone Gel-Filled Breast Implants
 
Mentor Worldwide LLC
201 Mentor Drive
Santa Barbara, CA 93111
 
Change to automate the Gel Mix material sampling process to be used in the production of MemoryShape, and MemoryGel Silicone Gel-filled Breast Implants manufactured at Mentor's Irving, Texas Facility.
 
P040020/S056
3/19/15
 
AcrySof® ReSTOR® Intraocular
 
Alcon Research, Ltd.
Fort Worth, TX 76134
 
Two alternate polypropylene resins, Basell PD702 and Total M3766.
 
P040027/S040
3/20/15
 
Gore VIATORR TIPS Endoprosthesis
 
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86003
 
Use of an ePTFE bonding film made from an alternate resin and the use of FEP film from an alternate supplier.
 
P040036/S049
3/19/15
 
ThermoCool SmartTouch Catheters
 
Biosense Webster, Inc.
Diamond Bar, CA 91765
 
Additional qualified supplier for extrusion and braiding processes.
 
P040036/S050
3/23/15
 
EZ Steer ThermoCool NAV
 
Biosense Webster, Inc.
Diamond Bar, CA 91765
 
Adding a second supplier for the 1mm sensor component used in the catheter families.
 
P040043/S072
3/31/15
 
GORE® TAG® Thoracic Endoprosthesis
 
W.L. Gore and Associates
Flagstaff, AZ 860003
 
Use film materials manufactured by Gore’s approved supplier on an alternating manufacturing line for GORE TAG Endoprosthesis and the GORE EXCLUDER AAA Endoprosthesis.
 
P050006/S046
3/19/15
 
Gore HELEX Septal Occluder
 
W.L. Gore & Flagstaff, AZ
86001
 
Modification to the PVA specification.
 
P050047/S045
3/4/15
 
Juvederm Hyaluronate Gel Implants
 
Allergan
Irvine, CA
92623
 
Scale-up of a gel compounding line in the Juvederm manufacturing process.
 
P050047/S046
3/26/15
 
Juvederm XC Hyaluronate Gel Implants
 
Allergan
Goleta, CA
93117
 
Expansion of the Pringy II manufacturing facility and associated minor changes to the utilities distribution system at the facility, to accommodate the added manufacturing space.
 
P060006/S065
3/6/15
 
Express SD Renal Premounted Stent System
 
Boston Scientific Corp.
Maple Grove, MN 55311
 
Modify the toolpath and software associated with the stent cutting lasers.
 
P060006/S066
3/17/15
 
Express SD Renal Premounted Stent System
 
Boston Scientific Corp.
Maple Grove, MN 55311
 
Software updates to the Full Body Stretcher of balloon components during the manufacturing process.
 
P060022/S021
3/20/15
 
Akreos Intraocular Lens (IOL)
 
Bausch & Lomb Incorporated
Irvine, CA
92618
 
Automated secondary packaging system.
 
P060027/S073
3/17/15
 
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR (ZL102), Intensia VR ICD, Intensia DR
 
Sorin CRM USA, Inc.
Arvada, CO
80004
 
Addition of Automated Optical Inspection (AOI) in manufacturing assembly line for the devices.
 
P060027/S074
3/13/15
 
Paradym CRT-D, Paradym RF
CRT-D, Paradym RF CRT-D, Intensia
 
Sorin CRM USA, Inc.
Arvada, CO
80004
 
Use of additional electrical welding equipment in the manufacturing laboratory.
 
P060027/S075
3/19/15
 
Paradym CRT-D, Paradym RF
CRT-D, Intensia CRT-D
 
Sorin CRM USA, Inc.
Arvada, CO
80004
 
Add an alternate supplier for the glue used in the die attach process for the hybrids used in the devices.
 
P060028/S006
3/5/15
 
Mentor MemoryShape Breast Implants
 
Mentor Worldwide LLC
Santa Barbara, CA 93111
 
Change to the assigned shelf life of the final gel mix, implementation of new equipment and a change to the gel mixture sampling procedure.
 
P060028/S007
3/17/15
 
MEMORYSHAPE Breast Implants
 
Mentor Worldwide LLC
Santa Barbara, CA 93111
 
Change to automate the Gel Mix material sampling process to be used in the production of MemoryShape, and MemoryGel Silicone Gel-filled Breast Implants manufactured at Mentor's Irving, Texas Facility.
 
P060028/S008
3/19/15
 
MEMORYSHAPE Breast Implants
 
Mentor Worldwide LLC
Santa Barbara, CA 93111
 
Changes in the production of MemoryShape Breast Implants manufactured at Mentor's Irving, Texas facility. The changes include expanding the gowning area, increasing the number of drying rods in the shell drying oven and updating the bowl fill procedure.
 
P060037/S034
3/27/15
 
NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee
 
Zimmer, Inc.
Warsaw, IN
46581
 
Incorporating the change in the device.
 
P060039/S066
3/2/15
 
Attain StarFix Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Addition of a new shrink wrap machine to the final packaging line.
 
P060040/S039
3/24/15
 
Thoratec HeartMate II Left Ventricular Assist System (LVAS)
 
Thoratec Corporation
Pleasanton, CA 94588
 
Alternate method for the molding process of the HeartMate II Percutaneous Cables.
 
P070026/S028
3/20/15
 
Ceramax Ceramic Total Hip System
 
DePuy Orthopedics, Inc.
Warsaw, IN
46581
 
Add 2D barcode laser etching manufacturing process.
 
P080006/S076
3/2/15
 
Attain Ability Lead, Attain Quadripolar Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Addition of a new shrink wrap machine to the final packaging line.
 
P080025/S086
3/6/15
 
InterStim Therapy System
 
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
 
Automate inspection of final device sealed tray package.
 
P080025/S087
3/26/15
 
Sacral Nerve Stimulation, Bowel Implantable Neurostimulator (INS) Interstim Family
 
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
 
Manufacturing change affecting the component of an implantable neurostimulator (INS) used for the Medtronic Neuromodulation Sacral Nerve Stimulation (SNS) therapies.
 
P080025/S088
3/27/15
 
InterStim Therapy System
 
Medtronic Inc.
Neuromodulation
Minneapolis, MN
55432
 
Transfer of incoming inspection activities for a number of components.
 
P090003/S038
3/6/15
 
Express LD Iliac Premounted Stent System
 
Boston Scientific Corp.
Maple Grove, MN 55311
 
Modify the toolpath and software associated with the stent cutting lasers.
 
P090013/S174
3/4/15
 
Revo MRI IPG
 
Medtronic, Inc.
Mounds View, MN 55112
 
Add alternative ultraviolet (UV) irradiator equipment in the manufacturing process for the devices.
 
P090013/S175
3/1/15
 
Revo MRI IPG
 
Medtronic Incorporated
Mounds View, MN 55112
 
Update the final visual inspection criteria for the hybrids used in the  devices.
 
P090013/S177
3/2/15
 
CapSureFix MRI Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Addition of a new shrink wrap machine to the final packaging line.
 
P090013/S178
3/11/15
 
CapSure Fix MRI Lead
 
Medtronic, Inc.
Mounds View, MN 55112
 
Updates to procedures for torque testing at final functional inspection.
 
P090016/S014
3/25/15
 
Belotero Balance Dermal Filler
 
Merz North America, Inc.
Franksville, WI 53126
 
Changes to the incoming inspection procedure for the Belotero balance dermal filler.
 
P100023/S114
3/17/15
 
ION™ (TAXUS™ Element™) Paclitaxel-Eluting Coronary Stent System
 
Boston Scientific Corp.
Maple Grove, MN 55311
 
Software updates to the Full Body Stretcher of balloon components during the manufacturing process.
 
P100026/S030
3/6/15
 
NeuroPace RNS System
 
NeuroPace, Incorporated
Mountain View, CA 94043
 
Modify the manufacturing and inspection process for the Wand (W-2).
 
P100027/S021
3/19/15
 
INFORM HER2 Dual ISH DNA Probe Cocktail
 
Ventana Medical Systems, Inc.
Tucson, AZ
85755
 
Change in the metric used to monitor the manufacturing process of the INFORM HER2 Dual ISH DNA Probe Cocktail. In addition, the metric change, an increase in the number of slides tested for final acceptance testing, as well as an expansion of that final acceptance testing to include gastric tissue, will be implemented.
 
P100041/S066
3/20/15
 
Edwards SAPIEN Transcatheter Heart Valve and Accessories
 
Edwards Lifesciences LLC
Irvine, CA
92614
 
Add a chamber to the ethylene oxide sterilization process at the Sterigenics facility (Salt Lake City, Utah).
 
P100047/S056
3/25/15
 
HeartWare® Ventricular Assist System
 
HeartWare, Inc.
Miami Lakes, FL 33014
 
Add an alternate second tier supplier and add a velour length trimming process for the HeartWare Ventricular Assist System.
 
P110001/S012
3/27/15
 
Rx Herculink Elite Renal Stent System
 
Abbott Vascular
Santa Clara, CA 95054
 
Addition of receiving inspection capabilities at the Clonmel, Ireland manufacturing site and contract laboratories.
 
P110010/S103
3/17/15
 
PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
 
Boston Scientific Corp.
Maple Grove, MN 55311
 
Software updates to the Full Body Stretcher of balloon components during the manufacturing process.
 
P110021/S053
3/20/15
 
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories
 
Edwards Lifesciences LLC
Irvine, CA
92614
 
Add a chamber to the ethylene oxide sterilization process at the Sterigenics facility (Salt Lake City, Utah).
 
P110028/S015
3/19/15
 
Absolute Pro Vascular Self-Expanding Stent System
 
Abbott Vascular
Santa Clara, CA 95054
 
Alternate resins in the manufacturing of the handle assembly for the Absolute Pro Vascular Self-Expanding Stent System.
 
P110033/S013
3/26/15
 
Juvederm Voluma XC
 
Allergan
Goleta, CA
93117
 
Expansion of the Pringy II manufacturing facility and associated minor changes to the utilities distribution system at the facility, to accommodate the added manufacturing space.
 
P110035/S030
3/6/15
 
Epic Vascular Self-expanding Stent System
 
Boston Scientific Corp.
Maple Grove, MN 55311
 
Modify the toolpath and software associated with the stent cutting lasers.
 
P110035/S031
3/27/15
 
Epic Vascular Self-Expanding Stent System
 
Boston Scientific Corp.
Maple Grove, MN 55311
 
Reduction to the post-electropolishing in-process monitoring inspections of the Epic stent component.
 
P120010/S063
3/23/15
 
MiniMed 530G System
 
Medtronic Inc.
Northridge, CA 91325
 
Modification to the laser cutting parameters for the Potomac Laser System used during the Enlite sensor manufacturing process in order to qualify it for use with the 48-UP sensor configuration. The Enlite Sensor is a component of the MiniMed 530G System.
 
P120016/S009
3/11/15
 
Vascade Vascular Closure System
 
Cardiva Medical, Inc.
Sunnyvale, CA 94085
 
Manufacturing of the Membrane Precondition subassembly in a new manufacturing facility located in Guaymas, Sonora Mexico.
 
P120016/S010
3/20/15
 
VASCADE Vascular Closure System
 
Cardiva Medical, Inc.
Sunnyvale, CA 94085
 
Transfer of the Push Rod subassembly to a new manufacturing location.
 
P120016/S011
3/26/15
 
VASCADE Closure System
 
Cardiva Medical, Inc.
Sunnyvale, CA 94085
 
Transfer of the Sleeve with Grip subassembly to a new manufacturing location.
 
P120016/S012
3/31/15
 
VASCADE™ Vascular Closure System
 
Cardiva Medical, Inc.
Sunnyvale, CA 94085
 
Transfer of the Epoxy Braid to Shaft subassembly to a new manufacturing location.
 
P120020/S007
3/6/15
 
Supera Peripheral Stent System
 
Abbott Vascular Inc.
Santa Clara, CA 95054
 
Addition of an alternate site for stent processing.
 
P130009/S029
3/20/15
 
Edwards SAPIEN XT Transcatheter Heart Valve and Accessories
 
Edwards Lifesciences LLC
Irvine, CA
92614
 
Add a chamber to the ethylene oxide sterilization process at the Sterigenics facility (Salt Lake City, Utah).
 
P130016/S011
3/13/15
 
Nucleus Hybrid L24 Implant
 
Cochlear Americas
Centennial, CO 80111
 
Addition of the helium bombing, and removal of gross leak test for the Magnet Assembly.
 
P130021/S011
3/31/15
 
Medtronic CoreValve System
 
Medtronic CoreValve LLC
Santa Rosa, CA 95403
 
Expand the capacity of the clean rooms used to manufacture the CoreValve Transcatheter Aortic Valve at the Medtronic Mexico facility.
 
P130030/S010
3/17/15
 
Rebel™ Platinum Chromium Coronary Stent System
 
Boston Scientific Corp.
Maple Grove, MN 55311
 
Software updates to the Full Body Stretcher of balloon components during the manufacturing process.
 

Summary of PMA Originals & Supplements Approved

  • Originals: 4
  • Supplements: 69

Summary of PMA Originals Under Review

  • Total Under Review: 61
  • Total Active: 29
  • Total On Hold: 32

Summary of PMA Supplements Under Review

  • Total Under Review: 571
  • Total Active: 417
  • Total On Hold: 154

Summary of All PMA Submissions

  • Originals: 4
  • Supplements: 93

Summary of PMA Supplement PMA Approval/Denial Decision Times

  • Number of Approvals: 69
  • Number of Denials: 0
  • Average Days Fr Receipt to Decision (Total Time): 120.1
  • FDA Time: 100.3 Days
  • MFR Time: 19.8 Days

 

Page Last Updated: 08/27/2015
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