Medical Devices

November 2013 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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P100026
11/14/13
RNS® SystemNeuroPace, Inc.
Mountain View, CA 94043
Approval for the RNS® System. This device is indicated as follows: " ... as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/ or secondarily generalized seizures). The RNS® System has demonstrated safety and effectiveness in patients who average 3 or more disabling seizures per month over the three most recent months (with no month with fewer than two seizures), and has not been evaluated in patients with less  frequent seizures."

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P790007/S040
11/14/13
Real-Time
Hancock® Modified Orifice (MO) Valved ConduitMedtronic, Inc.
Santa Ana, CA 92705
Approval for a design change to the rubber gasket for the jar used to package the device.
P810006/S036
11/29/13
135-Day
CollaStat Absorbable Collagen Hemostatic Sponge, CollaStat Absorbable Collagen Hemostatic Agent-Microfibrillar FormIntegra Life Sciences Corporation
Plainsboro, NJ 08536 
Approval for the following proposed changes: 1) change in cleaning detergents; 2) establishment of equipment Dirty Hold times (DHT); and 3) proposed use of Total Organic Carbons (TOCs) as a method to test for residues.
P830055/S129
11/29/13
180-Day
LCS Total Knee SystemDePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for manufacturing sites located at STERIS Isomedix, Chester, New York, and Synergy Health Switzerland, Däniken, Switzerland.  Both facilities will perform sterilization operations for the LCS Total Knee System.
P840062/S025
11/29/13
135-Day
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressing for Dental SurgeryIntegra Life Sciences Corporation
Plainsboro, NJ 08536
Approval for the following proposed changes: 1) change in cleaning detergents; 2) establishment of equipment Dirty Hold times (DHT); and 3) proposed use of Total Organic Carbons (TOCs) as a method to test for residues.
P850010/S033
11/29/13
135-Day
HeliStat, Helitene Absorbable Collagen Hemostatic AgentsIntegra Life Sciences Corporation
Plainsboro, NJ 08536 
Approval for the following proposed changes: 1) change in cleaning detergents; 2) establishment of equipment Dirty Hold times (DHT); and 3) proposed use of Total Organic Carbons (TOCs) as a method to test for residues.
P870078/S024
11/14/13
Real-Time
Hancock® Low- Porosity Valved ConduitMedtronic, Inc.
Santa Ana, CA 92705
Approval for a design change to the rubber gasket for the jar used to package the device.
P890003/S292
11/22/13
180-Day
CareLink Monitor, CardioSight Reader and Device Data Management ApplicationMedtronic, Inc.
Mounds View, MN 55112
Approval of the post-approval study protocol.
P890047/S042
11/13/13
180-Day
PROVISC® Improved Buffering Capacity (IBC) Ophthalmic Viscosurgical DeviceAlcon Laboratories, Inc.
Fort Worth, TX 76134
Approval to discontinue the current intravitreal test and replace it with the Inflammatory Release Assay for the PROVISC® IBC ophthalmic viscosurgical device.
P900033/S027
11/29/13
135-Day
Integra Dermal Regeneration TemplateIntegra Life Sciences Corporation
Plainsboro, NJ 08536 
 
Approval for the following proposed changes: 1) change in cleaning detergents; 2) establishment of equipment Dirty Hold times (DHT); and 3) proposed use of Total Organic Carbons (TOCs) as a method to test for residues.
P920015/S117
11/22/13
180-Day
Sprint Quattro Secura Defibrillators LeadMedtronic, Inc.
Mounds View, MN 55112
Approval of the post-approval study protocol.
P970003/S146
11/26/13
180-Day
VNS Therapy SystemCyberonics, Inc.
Houston, TX
77058
Approval for a labeling update to include the results of the D-21 Post Approval Study.
P970020/S077
11/26/13
135-Day
MULTILINK ULTRA RX and OTW Coronary Stent SystemsAbbott Vascular
Temecula, CA 92591
Approval for a change to the in-process stent sub-assembly inspection process.
P970051/S107
11/13/13
135-Day
Nucleus 24 Cochlear Implant SystemCochlear Americas
Centennial, CO 80111
Approval for introduction of a contained Helium leak test.
P980016/S441
11/22/13
180-Day
Secura DR, Secura VR, Maximo II DR Maximo II VR Implantable Cardioverter DefibrillatorsMedtronic, Inc.
Mounds View, MN 55112
Approval of the post-approval study protocol.
P980018/S018
11/26/13
Special
HercepTest™Dako Denmark A/S
Glostrup, Denmark
2600
Approval for labeling changes made to enhance safety of HercepTest™ when used for gastric and gastroesophageal cancer indications.
P000037/S033
135-Day
11/14/13
On-x Prosthetic Heart ValveOn-X Life Technologies, Inc.
Austin, TX
78752
Approval for several changes to the routine sterilization process.
P010013/S050
11/8/13
180-Day
NovaSure Impedance Controlled Endometrial Ablation SystemHologic, Inc.
Marlborough, MA 01752
Approval of the post-approval study protocol.
P010030/S402
11/22/13
180-Day
Consula CRT-D, Maximo II CRT-D Implantable Cardioverter Defibrillators with Resynchronization, Model 9995 Application Software v1.2 SystemsMedtronic, Inc.
Mounds View, MN 55112
Approval of the post-approval study protocol.
P010047/S028
11/8/13
180-Day
NeoMend Progel® Pleural Air Leak Sealant and Progel® Extended Applicator Spray TipNeomend, Inc.
Irvine, CA
92618
Approval of the post-approval study protocol.
P020024/S040
11/8/13
180-Day
Amplatzer Duct Occluder IIAGA Medical Corporation
Plymouth, MN 55442
Approval of the post-approval study protocol.
P020025/S045
11/25/13
Real-Time
IntellaTip Mifi Xp Ablation Catheter and AccessoriesBoston Scientific Corporation
San Jose, CA
95134
Approval to allow health care facilities to manually clean and re-sterilize the IntellaTip Mifi XP cable up to 10 times via ethylene oxide or steam after initial use of the cables.
P020025/S046
11/25/13
Real-Time
IntellaTip Mifi Xp Ablation Catheter and AccessoriesBoston Scientific Corporation
San Jose, CA
95134
Approval to change the shelf life of the IntellaTip Mifi XP ablation catheter from 6 months to 3 years.
P020050/S010
11/25/13
180-Day
WaveLight EX500 Excimer Laser SystemAlcon Laboratories, Inc.
Fort Worth, TX 76134
Approval for a registration feature that enables Pupil Center Shift Compensation and Cyclotorsion Adjustment based on comparison of diagnostic and treatment images.
P030008/S009
11/25/13
180-Day
WaveLight EX500 Excimer Laser SystemAlcon Laboratories, Inc.
Fort Worth, TX 76134
Approval for a registration feature that enables Pupil Center Shift Compensation and Cyclotorsion Adjustment based on comparison of diagnostic and treatment images.
P030054/S246
11/14/13
Real-Time
Left Ventricular Lead FamiliesSt. Jude Medical
Sylmar, CA
91342
Approval for a modification to the weld shaft component on 1258T and 1458Q lead families.
P040021/S024
11/7/13
135-Day
Biocor/Epic™ ValveSt. Jude Medical
St. Paul, MN
55117
Approval for an alternate vendor for the jar and lid components as well as a change to the jar tooling.
P040034/S021
11/15/13
135-Day
DuraSeal Dural Sealant SystemCovidien
North Haven, CT 06473
Approval for a change to the layering of kits in the case box used for sterilization.
P050034/S009
11/5/13
180-Day
Implantable Miniature TelescopeTM (IMT)VisionCare Ophthalmic Technologies
Saratoga, CA
95070
Approval for modifications to the approved Professional Use Information and Patient Information Booklet to add information obtained from Post-Approval Study IMT-002- LTME.
P050044/S025
11/15/13
180-Day
Vitagel® RT3™ Surgical HemostatOrthovita, Inc. “dba” Stryker Orthobiologics
Malvern, PA
19355
Approval for a device name change for the Vitagel® RT Surgical Hemostat. The device, as modified, will be marketed under the trade name Vitagel® RT3™ Surgical Hemostat with no change in the indications for use.
P050047/S031
11/26/13
Real-Time
Juvéderm Hyaluronate Gel ImplantsAllergan
Goleta, CA
93117
Approval for change to the concentration of the lidocaine solution introduced to the gel during the homogenization step from 50% w/w to 30% w/v lidocaine hydrochloride and a revalidation, by weight, the amount of gel that can be mixed during the homogenization step of the manufacturing process.
P060039/S049
11/19/13
180-Day
Attain StarFixMedtronic, Inc.
Mounds View, MN 55112
Approval of the post-approval study protocol.
P070026/S016
11/21/13
180-Day
CERAMAX® Ceramic Total Hip SystemDePuy Synthes
Warsaw, IN
46581
Approval of the post-approval study.
P080013/S009
11/15/13
135-Day
DuraSeal Exact Spine Sealant SystemCovidien
North Haven, CT 06473
Approval for a change to the layering of kits in the case box used for sterilization.
P090018/S024
 11/4/13
Real-Time
EsteemEnvoy Medical Corporation
Saint Paul, MN 55110
Approval for changes to the Intraoperative System Analyzer (ISA) software.
P100029/S016
11/7/13
135-Day
Trifecta™ ValveSt. Jude Medical
St. Paul, MN
55117
Approval for an alternate vendor for the jar and lid components as well as a change to the jar tooling.
P100030/S001
11/25/13
Real-Time
ArterX® Surgical SealantTenaxis Medical, Inc.
Mountain View, CA 94043
Approval for the addition of 2.5mL and 5.0mL fill volumes to the existing 4.0mL fill volume, using the same 5mL syringe and packaging.
P100030/S002
11/5/13
Real-Time
ArterX Surgical SealantTenaxis Medical, Inc.
Mountain View, CA 94043
Approval to extend the shelf life for ArterX Surgical Sealant from 12 months to 24 months when stored at 2-8°C and to extend the shelf life for the ArterX Delivery Tips from 12 months to 42 months.
P100041/S043
11/18/13
Special
Edwards SAPIEN™ Transcatheter Heart Valve and Transfemoral AccessoriesEdwards Lifesciences, LLC
Irvine, CA
92614
Approval for modifying inspection of the y-connector to guidewire shaft and associated changes to the manufacturing procedure documentation.
P100047/S024
11/15/13
180-Day
HeartWare Ventricular Assist SystemHeartWare, Inc.
Miami, FL
33014
Approval of the post-approval study.
P100047/S025
11/15/13
180-Day
HeartWare Ventricular Assist SystemHeartWare, Inc.
Miami, FL
33014
Approval of the post-approval study.
P110010/S053
111/21/13
180-Day
Promus PREMIER™ Everolimus-Eluting Platinum-Chromium Coronary Stent System (Monorail™ and Over-The-Wire)Boston Scientific Corporation
Maple Grove, MN 55311
Approval for the following changes to the PROMUS® Element™ Plus Everolimus-Eluting Platinum-Chromium Coronary Stent System: stent design modifications to increase axial strength, a shorter tip and colorant change on the stent delivery system, modifications to the hypotube covering on the stent delivery system, and labeling changes. The device, as modified, will be marketed under the trade name Promus PREMIER™ Everolimus- Eluting Platinum Chromium Coronary Stent System.
P110013/S015
11/7/13
135-Day
 Resolute Integrity Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Approval for changes to the components and the software of the drug spray machine.
P110021/S030
11/18/13
Special
Edwards SAPIENTM Transcatheter Heart Valve and Transfemoral and Transapical AccessoriesEdwards Lifesciences, LLC
Irvine, CA
92614
Approval for modifying inspection of the y-connector to guidewire shaft and associated changes to the manufacturing procedure documentation.
P110032/S006
11/21/13
Special
Aorfix™ AAA Flexible Stent Graft SystemLombard Medical Technologies, Inc.
Tempe, AZ
85284
Approval for revised Instructions for Use (IFU) to add warnings and precautions based on data from ongoing follow-up of subjects in the IDE study.
P120007/S001
11/6/13
180-Day
APTIMA® HPV 16 18/45 Genotype AssayGen-Probe Incorporated
San Diego, CA 92121
Approval for the addition of the PANTHER System to the APTIMA® HPV 16 18/45 Genotype Assay. The device, as modified, will be marketed under the trade name APTIMA® HPV 16 18/45 Genotype Assay. The APTIMA HPV 16 18/45 Genotype Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18, and 45 in cervical specimens from women with APTIMA HPV Assay positive results. The APTIMA HPV 16 18/45 Genotype Assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the APTIMA HPV 16 18/45 Genotype Assay. The assay is used with the TIGRIS DTS System or the PANTHER System. The use of the test is indicated: 1) In women 21 years and older with atypical squamous cells of undetermined significance (AS-CUS) cervical cytology results, the APTIMA HPV 16 18/45 Genotype Assay can be used to test samples from women with APTIMA HPV Assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy; and 2) In women 30 years and older, the APTIMA HPV 16 18/45 Genotype Assay can be used to test samples from women with APTIMA HPV Assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. *Broom-type device (e.g., Wallach Pipette) or endocervical brush/spatula.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N970003/S157
11/26/13
FORMIO, VITALIO, ADVANTIO, INGENIO, ALTRUA, INSIGNIA PacemakersBoston Scientific Corporation
St. Paul, MN
55112
Add instructions for cleaning the seal plug bond area of the polyurethane headers of the devices to the appropriate work instructions.
P820003/S125
11/19/13
Disposable EPG CoverMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P830061/S099
11/19/13
CapSure, Viatron Lead familiesMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P830061/S100
11/26/13
CapSure, Viatron Lead FamiliesMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P840001/S254
11/20/13
RestoreAdvanced® Neurostimulator; RestoreAdvanced® MRI Rechargeable NeurostimulatorMedtronic Neuromodulation
Minneapolis, MN 55432
Changes to the manufacturing test methodology (final functional test) for hybrids that are used to build implantable neurostimulators.
P840001/S255
11/22/13
Itrel 4 Implantable Neurostimulator, Itrel 3 Implantable Neurostimulator RestorePrime Implantable Neurostimulator  PrimeAdvanced Implantable Neurostimulator, Restore Implantable Neurostimulator, RestoreUltra Implantable Neurostimulator, RestoreAdvanced Implantable Neurostimulator, RestoreSensor Implantable Neurostimulator, PrimeAdvanced SureScan MRI Neurostimulator, RestoreUltra SureScan MRI Rechargeable Neurostimulator, RestoreAdvanced SureScan MRI Rechargeable Neurostimulator, RestoreSensor SureScan MRI Rechargeable Neurostimulator, Synergy Implantable NeurostimulatorMedtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Addition of a new epoxy mixer component for the MTA epoxy dispenser at Medtronic final assembly device manufacturing facility for the affected products.
P840001/S256
11/27/13
Revision Kit, 1x8 Subcompact Lead Kit, 1x8 Standard Lead Kit, 1x8 Compact Lead Kit, Octad Lead, 1x8 Low Impedance Lead Kit, 1x8 Compact Low Impedance Lead Kit, Vectris SureScan MRI 1x8 Subcompact, Vectris SureScan MRI 1x8 Subcompact, Vectris SureScan MRI 1x8 Subcompact, Vectris SureScan MRI 1x8 Compact, Vectris SureScan MRI 1x8 Compact, Vectris SureScan MRI 1x8 Compact, Pisces-Quad Lead Kit, Pisces-Quad Compact Lead Kit, Pisces-Quad Plus Lead Kit, Lead Revision Kit, Lead Revision Kit, 1x8 Lead Revision Accessory Kit, 1x8 Lead Revision Accessory Kit, Vectris 1x8 Subcompact, Vectris 1x8 CompactMedtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Move the manufacturing of the guidewire from one building to another building on the same campus.
P850089/S102
11/19/13
CapSure SP, Capsure Z, Viatron II Lead FamiliesMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P850089/S103
11/26/13
CapSure SP, Capsure Z, Viatron II Lead FamiliesMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P860057/S114
11/26/13
Carpentier-Edwards PERIMOUNT BioprosthesisEdwards Lifesciences, LLC
Irvine,CA
92614
Addition of a new clean room and two additional pieces of associated equipment at an existing manufacturing facility.
P890003/S289
11/19/13
CapSure Leads, Pacemaker Repair KitMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P890003/S291
11/26/13
CapSure leads, Pacemaker Repair KitMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P890057/S021
11/22/14
CareFusion 3100 High Frequency Oscillating Ventilator (HFOV)CareFusion
Yorba Linda, CA 92887
Change to add a supplier for the stopcock.
P900061/S123
11/19/13
Epicardial Patch Lead, ACE Header, End CapMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P900061/S124
11/26/13
Epicardial Patch Lead, ACE Header, End CapMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P910007/S040
11/26/13
ARCHITECT Total PSAAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Replacement of a quality control test with a new quality control test for an incoming raw material.
P910007/S041
11/26/13
ARCHITECT Total PSAAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Addition of a quality control test method for incoming lots of Triton X-100.
P910023/S322
11/26/13
Fortify ICDsSt. Jude Medical
Sylmar, CA
91342
Change to a tool used during device manufacturing.
P920015/S121
11/19/13
Transvene Leads, Sprint Quattro Lead Family, Y-Adaptor, Pin PlugMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P920015/S123
11/26/13
Transvene Leads, Sprint Quattro Lead Family, Y-Adaptor, Pin PlugMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P930029/S095
11/19/13
CapSureFix, SureFix, TorClipMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P930039/S096
11/26/13
CapSureFix, SureFix, TorClipMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P950005/S048
11/26/13
Celsius FLTR Bi-directional CatheterBiosense Webster, Inc.
Diamond Bar, CA 91765
Change to the oven parameters in the tip reflow process and implementation of a new inspection.
P950008/S011
11/22/13
SILIKON 1000 Retinal TamponadeAlcon Laboratories, Inc.
Fort Worth, TX 76134
Alternate reagent supplier.
P950024/S053
11/19/13
CapSure Epicardial LeadsMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P950024/S054
11/26/13
CapSure Epicardial LeadsMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P950029/S085
11/26/13
Reply SR, Reply DR, Esprit SR, Esprit DRSorin CRM USA, Inc.
Arvada, CO
80004
Alternate equipment for polymerization, plasma cleaning, and wire bonding that is used to manufacture the devices.
P960009/S185
11/22/13
Activa PC Implantable Neurostimulator, Activa SC Implantable Neurostimulator, Activa RC Implantable Neurostimulator, Soletra Implantable NeurostimulatorMedtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Addition of a new epoxy mixer component for the MTA epoxy dispenser at Medtronic final assembly device manufacturing facility for the affected products.
P960040/S307
11/26/13
PUNCTUA, TELIGEN, ENERGEN, INCEPTA, VITALITY, Implantable Cardioverter Defibrillators (ICDs)Boston Scientific Corporation
St. Paul, MN
55112
Add instructions for cleaning the seal plug bond area of the polyurethane headers of the devices to the appropriate work instructions.
P970004/S164
11/22/13
InterStim Implantable Neurostimulator, InterStim II Implantable NeurostimulatorMedtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Addition of a new epoxy mixer component for the MTA epoxy dispenser at Medtronic final assembly device manufacturing facility for the affected products.
P970020/S078
11/14/13
MULTILINK ZETA CSSAbbott Vascular
Temecula, CA 92591
Addition of an alternate supplier for the adaption cup components used to manufacture the  devices.
P980007/S031
11/26/13
ARCHITECT Free PSAAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Replacement of a quality control test with a new quality control test for an incoming raw material.
P980007/S032
11/26/13
ARCHITECT Free PSAAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Addition of a quality control test method for incoming lots of Triton X-100.
P980016/S445
11/19/13
Evera, Maximo, Protecta, Secura, Virtuoso ICDsMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P980024/S011
11/27/13
PathVysion HER-2 DNA Probe KitAbbott Molecular, Inc.
Des Plaines, IL 60018
Changing the configuration of their current label printer, label printing software, and label inspection system for the following FISH assays: Vysis ALK Break Apart Fish Probe Kit, UroVysion Bladder Cancer Kit, and PathVysion Her-2DNA Probe Kit.
P980035/S349
11/14/13
Advisa DR MRI IPGMedtronic CRDM
Mounds View, MN 55112
Addition of a second laser welder to the battery manufacturing line of the devices.
P980035/S350
11/14/13
Advisa DR IPG and Advisa DR MRI IPGMedtronic CRDM
Mounds View, MN 55112
Use of an additional leak test station at the battery supplier.
P980035/S351
11/19/13
Advisa DR IPG and Advisa DR MRI IPGMedtronic CRDM
Mounds View, MN 55112
Modification in a laser seam welder.
P980035/S352
11/21/13
Adapta, Versa, and Sensia IPGsMedtronic CRDM
Mounds View, MN 55112
Modification to the laser ribbon bonding processing parameters.
P980035/S353
11/19/13
Advisa DR IPG, Advisa DR MRI IPGMedtronic, Inc.
Mounds View, MN 55112
Additional workstations used at the medium rate battery supplier.
P980035/S354
11/19/13
Adapta, Vera, Sensia, Advisa, Relia IPGsMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P980049/S089
11/26/13
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DRSorin CRM USA, Inc.
Arvada, CO
80004
Alternate equipment for polymerization, plasma cleaning, and wire bonding that is used to manufacture the devices.
P980050/S086
11/19/13
Transvene CS/SVC LeadMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P980050/S087
11/26/13
Transvene CS/SVC LeadMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P990081/S023
11/15/13
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
Automation of testing processes (currently performed semi-manually) using the new automated Dispenser Verification Module (DVM).
P010012/S342
11/26/13
COGNIS, ENERGEN, INCEPTA, PUNCTUA Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds)Boston Scientific Corporation
St. Paul, MN
55112
Add instructions for cleaning the seal plug bond area of the polyurethane headers of the devices to the appropriate work instructions.
P010015/S223
11/14/13
Consulta CRT-P and Syncra CRT-PMedtronic, Inc.
Mounds View, MN 55112
Use of an additional leak test station at the battery supplier.
P010015/S224
11/19/13
Consulta CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN 55112
Additional workstations used at the medium rate battery supplier.
P010015/S225
11/19/13
Attain OTW leads, Consulta CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P010015/S226
11/26/13
Attain OTW and LV leadsMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P010031/S406
11/19/13
Brava, Concerto, Consulta, Maximo, Protecta, Viva CRT-DsMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P010068/S037
11/26/13
Celsius FLTR Uni-directional CatheterBiosense Webster, Inc.
Diamond Bar, CA 91765
Change to the oven parameters in the tip reflow process and implementation of a new inspection.
P020004/S088
11/25/13
EXCLUDER AAA EndoprosthesisW.L. Gore & Associates
Flagstaff, AZ
86001
Implement the use of alternate polytetrafluoroethylene (PTFE) resin raw material.
P020047/S056
11/14/13
VISION RX, MINI VISION RX, MULTILINK 8 Coronary Stent SystemAbbott Vascular
Temecula, CA 92591
Addition of an alternate supplier for the adaption cup components used to manufacture the  devices.
P020055/S011
11/15/13
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
Automation of testing processes (currently performed semi-manually) using the new automated Dispenser Verification Module (DVM).
P030005/S104
11/26/13
INVIVE, INTUA, Cardiac Resynchronization Therapy-Pacemakers (CRT-Ps)Boston Scientific Corporation
St. Paul, MN
55112
Add instructions for cleaning the seal plug bond area of the polyurethane headers of the devices to the appropriate work instructions.
P030036/S065
11/19/13
SelectSecure Lead, Lead Anchor SleeveMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P030036/S066
11/26/13
SelectSecure Lead, Lead Anchor SleeveMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P030052/S013
11/27/13
UroVysion Bladder Cancer KitAbbott Molecular, Inc.
Des Plaines, IL 60018
Changing the configuration of their current label printer, label printing software, and label inspection system for the following FISH assays: Vysis ALK Break Apart Fish Probe Kit, UroVysion Bladder Cancer Kit, and PathVysion Her-2DNA Probe Kit.
P030054/S253
11/26/13
Unify and Unify Quadra CRT-DsSt. Jude Medical
Sylmar, CA
91342
Change to a tool used during device manufacturing.
P040037/S058
11/24/13
GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Modify the process settings of a bonding process.
P040037/S059
11/25/13
TAG Thoracic EndoprosthesisW.L. Gore & Associates
Flagstaff, AZ
86001
Implement the use of alternate polytetrafluoroethylene (PTFE) resin raw material.
P040047/S030
11/21/13
Coaptite Injectable ImplantMerz North America, Inc.
Franksville, WI 53126
Elimination of a redundant drying test.
P050006/S037
11/25/13
HELEX Septal OccluderW.L. Gore & Associates
Flagstaff, AZ
86001
Implement the use of alternate polytetrafluoroethylene (PTFE) resin raw material.
P050037/S043
11/27/13
Radiesse Dermal FillerMerz North America, Inc.
Franksville, WI 53126
Elimination of a test performed on the Radiesse Dermal Filler.
P050042/S026
11/15/13
ARCHITECT Anti-HCVAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Change to a test method for evaluation of incoming and recalcified anti-HCV negative human plasma.
P050042/S027
11/26/13
ARCHITECT Anti-HCVAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Replacement of a quality control test with a new quality control test for an incoming raw material.
P050042/S028
11/26/13
ARCHITECT Anti-HCVAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Addition of a quality control test method for incoming lots of Triton X-100
P050051/S023
11/26/13
ARCHITECT AUSABAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Replacement of a quality control test with a new quality control test for an incoming raw material.
P050051/S024
11/26/13
ARCHITECT AUSABAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Addition of a quality control test method for incoming lots of Triton X-100
P050052/S046
11/27/13
Radiesse Dermal FillerMerz North America, Inc.
Franksville, WI 53126
Elimination of a test performed on the Radiesse Dermal Filler.
P060027/S057
11/26/13
 
Paradym CRT-D, Paradym RF CRT-DSorin CRM USA, Inc.
Arvada, CO
80004
Alternate equipment for polymerization, plasma cleaning, and wire bonding that is used to manufacture the devices.
P060035/S021
11/26/13
ARCHITECT CORE-MAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Replacement of a quality control test with a new quality control test for an incoming raw material.
P060035/S022
11/26/13
ARCHITECT CORE-MAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Addition of a quality control test method for incoming lots of Triton X-100
P060038/S018
11/22/13
Mitroflow Aortic Pericardial Heart ValveSorin Group USA, Inc.
Arvada, CO
80004
Change the supplier to perform analysis on receiving materials from an external contract laboratory to in-house.
P060039/S049
11/19/13
Attain StarFix LeadMedtronic, Inc.
Mounds View, MN 55112
Approval of the post-approval study protocol.
P060039/S052
11/19/13
Attain StarFix LeadMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P060039/S053
11/26/13
Attain StarFix LeadMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P070015/S115
11/14/13
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) and XIENCE nano EECSS (XIENCE nano)Abbott Vascular
Temecula, CA 92591
Addition of an alternate supplier for the adaption cup components used to manufacture the  devices. Edwards SAPIEN™ Transcatheter Heart Valve and Accessories.
P070015/S116
11/20/13
Xience V Everolimus-Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA 92591
Addition of receiving inspection and testing activities of drug materials at the Clonmel, Ireland facility and a contract laboratory.
P080006/S059
11/19/13
Attain Ability Lead FamilyMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P080006/S060
11/26/13
Attain Ability Lead FamilyMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P080023/S023
11/26/13
ARCHITECT COREAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Replacement of a quality control test with a new quality control test for an incoming raw material.
P080023/S024
11/26/13
ARCHITECT COREAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Addition of a quality control test method for incoming lots of Triton X-100.
P080025/S060
11/22/13
InterStim Implantable Neurostimulator, InterStim II Implantable NeurostimulatorMedtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Addition of a new epoxy mixer component for the MTA epoxy dispenser at Medtronic final assembly device manufacturing facility for the affected products.
P080026/S010
11/19/13
Abbott RealTime HBV AssayAbbott Molecular
Des Plaines, IL 60018
Manufacturing process changes and QC in-process method changes to synthesize oligonucleotides on a larger scale.
P090013/S116
11/14/13
Revo MRI IPGMedtronic CRDM
Mounds View, MN 55112
Addition of a second laser welder to the battery manufacturing line of the devices.
P090013/S117
11/14/13
Revo MRI IPGMedtronic CRDM
Mounds View, MN 55112
Use of an additional leak test station at the battery supplier.
P090013/S118
11/19/13
Revo MRI IPGMedtronic, Inc.
Mounds View, MN 55112
Additional workstations used at the medium rate battery supplier.
P090013/S119
11/19/13
CapSureFix MRI Lead, Revo MRI IPGMedtronic, Inc.
Mounds View, MN 55112
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities.
P090013/S120
11/26/13
CapSureFix MRI Lead, Revo MRI IPGMedtronic, Inc.
Mounds View, MN 55112
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities.
P100017/S008
11/19/13
Abbott RealTime HCV AssayAbbott Molecular
Des Plaines, IL 60018
Manufacturing process changes and QC in-process method changes to synthesize oligonucleotides on a larger scale.
P100027/S012
11/15/13
INFORM HER2 Dual ISH DNA ProbeVentana Medical Systems, Inc.
Tucson, AZ
85755
Automation of testing processes (currently performed semi-manually) using the new automated Dispenser Verification Module (DVM).
P100041/S042
11/26/13
Edwards SAPIEN™ Transcatheter Heart Valve and AccessoriesEdwards Lifesciences LLC
Irvine, CA
92614
Implementation of an automated tube cutting fixture to replace manual cutting.
P110012/S005
11/27/13
Vysis ALK Break Apart FISH Probe KitAbbott Molecular, Inc.
Des Plaines, IL 60018
Changing the configuration of their current label printer, label printing software, and label inspection system for the following FISH assays: Vysis ALK Break Apart Fish Probe Kit, UroVysion Bladder Cancer Kit, and PathVysion Her-2DNA Probe Kit.
P110019/S056
11/14/13
XIENCE PRIME EECSS (XIENCE PRIME and XIENCE PRIME Long Lengths)Abbott Vascular
Temecula, CA 92591
Addition of an alternate supplier for the adaption cup components used to manufacture the  devices.
P110019/S057
11/14/13
Xience Prime Everolimus-Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA 92591
Addition of receiving inspection and testing activities of drug materials at the Clonmel, Ireland facility and a contract laboratory.
P110021/S029
11/26/13
Edwards SAPIEN™ Transcatheter Heart Valve and AccessoriesEdwards Lifesciences LLC
Irvine, CA
92614
Implementation of an automated tube cutting fixture to replace manual cutting.
P110029/S014
11/26/13
ARCHITECT HBsAg Qualitative and HBsAg Qualitative ConfirmatoryAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Replacement of a quality control test with a new quality control test for an incoming raw material.
P110029/S015
11/26/13
ARCHITECT HBsAg Qualitative and HBsAg Qualitative ConfirmatoryAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Addition of a quality control test method for incoming lots of Triton X-100.
P110029/S016
11/26/13
ARCHITECT HBsAg Qualitative and Qualitative ConfirmatoryAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Change in an incoming Quality Control method for anti-HBs negative plasmas.
P110035/S023
11/24/13
Epic Vascular Self-Expanding Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change the data collection method and frequency in the extrusion manufacturing process.
P110037/S012
11/26/13
COBAS® AmpliPrep/ COBAS® TaqMan® CMV TestRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Adjustment to the pH range for the Lysis Reagent.
P110040/S001
11/24/13
Complete SE Vascular Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Modify the bonding process for the stability member subcomponent of the delivery system.
P110042/S018
11/21/13
S-ICD SystemCameron Health, Inc.
San Clemente, CA 92673
Implement an automated High Power Hybrid (HPH) Resistance Screening System and corresponding 100% inspection process.
P110042/S019
11/26/13
Subcutaneous Implantable Defibrillator (S-ICD) SystemCameron Health, Inc.
Clemente, CA 92673
Insourcing of the Q-GUIDE Electrode Insertion Tool.
P120008/S004
11/26/13
ARCHITECT AFPAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Replacement of a quality control test with a new quality control test for an incoming raw material.
P120008/S005
11/26/13
ARCHITECT AFPAbbott Laboratories, Diagnostics
Abbott Park, IL 60064
Addition of a quality control test method for incoming lots of Triton X-100.

Summary of PMA Originals & Supplements Approved
Originals: 1 
Supplements: 45

Summary of PMA Originals Under Review
Total Under Review: 52
Total Active: 20
Total On Hold: 32

Summary of PMA Supplements Under Review
Total Under Review: 600
Total Active: 415
Total On Hold: 185

Summary of All PMA Submissions Received
Originals: 3
Supplements: 87

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 45
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 141.4
FDA Time: 109.3 Days  MFR Time: 32.1 Days

Page Last Updated: 06/17/2014
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