• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

February 2011 PMA Approvals

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

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
P080003
2/11/11
Selenia Dimensions 3D SystemHologic, Inc.
Bedford, MA
01730
Approval for the Selenia Dimensions 3D System. This device is indicated to generate digital mammographic images that can be used for screening and diagnosis of breast cancer. The Selenia Dimensions (2D or 3D) system is intended for use in the same clinical applications as 2D mammography systems for screening mammograms. Specifically, the Selenia Dimensions system can be used to acquire 2D digital mammograms and 3D mammograms. The screening examination will consist of a 2D image set or a 2D and 3D image set. The Selenia Dimensions system may also be used for additional diagnostic workup of the breast.
P090013
2/8/11
Revo MRI™ SureScan™ Pacing SystemMedtronic, Inc.
Mounds View, MN
55112
Approval for the Revo MRI SureScan Pacing System, which consists of the Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG, the Medtronic CapSureFix MRI™ SureScan™ 5086MRI lead, and the Revo MRI™ Software Application Model SW018. This system is indicated as follows:
The Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG is indicated for use as a system consisting of a Revo MRI SureScan IPG implanted with two CapSure Fix MRI™
SureScan™ 5086MRI leads. A complete system is required for use in the MRI environment.
The Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG is indicated for the following:
1) Rate adaptive pacing in patients who may benefit from increased pacing rales
concurrent with increases in activity;
2) Accepted patient conditions warranting chronic cardiac pacing include:
a) symptomatic paroxysmal or permanent second-degree or third-degree AV block;
b) symptomatic bilateral bundle branch block;
c) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders; and
d) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias.
The device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV
synchrony, which include:
1) Various degrees of AV block to maintain the atrial contribution to cardiac output; and
2) VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm.
Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmia in bradycardia patients with one or more of the above pacing indications.
Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmia in bradycardia patients with atrial septal lead placement and one or more of the above pacing indications.
The Medtronic CapSureFix MRI™ SureScan™ 5086MRI lead is indicated for use as a system consisting of a Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG implanted with two SureScan leads. A complete system is required for use in the MRI environment.
This lead has application where implantable dual chamber MR Conditional pacing systems are indicated.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P830055/S107
2/22/11
180-Day
LCS Total Knee SystemDePuy Orthopaedics, Inc. Warsaw, IN
46581
Approval to manufacture the P.F.C. Sigma RP-F, LCS Complete RP, and RPS Tibial Inserts from GUR 1020 polyethylene with an antioxidant (AOX), to change the packaging components and materials, and to request approval of a shelf-life testing protocol for the P.F.C. Sigma RP-F, LCS Complete RP and RPS Tibial Inserts.
P850048/S024
2/7/11
Special
Access® Hybritech® PSA Reagents on the Access® Immunoassay SystemsBeckman Coulter, Inc.
Chaska, MN
55318
Approval to add the following new warning label to all Access DxI systems. “Warning” Erroneous results can occur if reagent packs are not loaded properly. 1) Never transfer a partial reagent pack that was used on a different system.
2) Always load a reagent pack before scanning the bar code (Access/
Access 2 only). For specific instructions, consult the system documentation.
P850048/S025
2/4/11
Special
Access® Hybritech® PSA Reagents on the Access® Immunoassay SystemsBeckman Coulter, Inc.
Chaska, MN
55318
Approval for the following changes: 1) modify the fluidics interconnect panels to add tube clips; 2) additional tubing labels which correspond with fluidic interconnect panel; 3) add strain relief as a bend deterrent; and 4) update maintenance documentation to reflect modified configuration.
P910073/S092
2/11/11
Real-Time
RELIANCE 4-Site Defibrillation LeadBoston Scientific
St. Paul, MN
55112
Approval for a decrease in the length of the polyurethane tubing present at the proximal end of the lead and a labeling note regarding implantation technique.
P950005/S031
2/3/11
180-Day
Celsius RMT Catheter (4mm)Biosense Webster Diamond Bar, CA 91765Approval for a manufacturing site located at Biosense Webster, Inc, Juarez, Mexico.
P950032/S059
2/14/11
135-Day
Apligraf®Organogensis Incorporated
Canton, MA
02021
Approval to use a rapid microbial method, as an alternate sterility testing method for all in-process liquid samples currently tested per United States Pharmacopeia <71>, Sterility Tests.
P950037/S092
2/11/11
Real-Time
Estella DR ;
Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T;
Effecta D; Effecta DR; Effecta S; and Effecta SR
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The modified devices will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR.
P960013/S063
2/3/11
135-Day
Tendril LeadsSt. Jude Medical, Inc.
Sylmar, CA
91392
Approval for the use of an alternate supplier for the manufacture of shaft assemblies.
P960022/S007
2/18/11
180-Day
Bausch & Lomb® SofLens® Toric (alphafilcon A) Visibility Tinted Contact LensesBausch & Lomb, Inc.
Rochester, NY
14609
Approval for a name change to the currently marketed Bausch & Lomb® SofLens® 66 Toric (alphafilcon A) Visibility tinted Contact Lenses. The proposed name for the device is Bausch & Lomb® SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses.
P970038/S013
2/7/11
Special
Access® Hybritech® Free PSA Reagents on the Access® Immunoassay SystemsBeckman Coulter, Inc.
Chaska, MN
55318
Approval to add the following new warning label to all Access DxI systems. “Warning” Erroneous results can occur if reagent packs are not loaded properly. 1) Never transfer a partial reagent pack that was used on a different system. 2) Always load a reagent pack before scanning the bar code (Access/
Access 2 only). For specific instructions, consult the system documentation.
P970038/S014
2/4/11
Special
Access® Hybritech® Free PSA Reagents on the Access® Immunoassay SystemsBeckman Coulter, Inc.
Chaska, MN
55318
Approval for the following changes: 1) modify the fluidics interconnect panels to add tube clips; 2) additional tubing labels which correspond with fluidic interconnect panel; 3) add strain relief as a bend deterrent; and 4) update maintenance documentation to reflect modified configuration.
P980018/S011
2/17/11
180-Day
Herceptest™ KitDako Denmark A/S Glostrup, Denmark
DK-2600
Approval of the DakoLink v3.1.0. software for Herceptest™ kit.
P980022/S087
2/17/11
135-Day
Paradigm Real Time SystemMedtronic, Inc. Northridge, CA 91325Approval of the addition of an alternate vendor for the Dynaroll battery tube.
P980023/S043
2/28/11
Real-Time
Linox smart S and Linox smart T Steroid- Eluting Single Coil ICD LeadsBiotronik, Inc.
Lake Oswego, OR
97035
Approval for: 1) addition of Silglide surface treatment of the silicone lead body; 2) increase in outer diameter of lead body at DF-1 connector exit; and 3) additional suppliers for silicone and conductor materials.
P980041/S014
2/7/11
Special
Access® AFP Reagents on the Access® Immunoassay SystemsBeckman Coulter, Inc.
Chaska, MN
55318
Approval to add the following new warning label to all Access DxI systems. “Warning” Erroneous results can occur if reagent packs are not loaded properly. 1) Never transfer a partial reagent pack that was used on a different system. 2) Always load a reagent pack before scanning the bar code (Access/
Access 2 only). For specific instructions, consult the system documentation.
P980041/S015
2/4/11
Special
Access® AFP Reagents on the Access® Immunoassay SystemsBeckman Coulter, Inc.
Chaska, MN
55318
Approval for the following changes: 1) modify the fluidics interconnect panels to add tube clips; 2) additional tubing labels which correspond with fluidic interconnect panel; 3) add strain relief as a bend deterrent; and 4) update maintenance documentation to reflect modified configuration.
P980049/S062
2/10/11
Real-Time
Paradym ICD and CRT-DELA Medical, Inc./ Sorin Group
Plymouth, MN 5541
Approval for the changes to the transformer, Opto Wedge, and Desiccant for the Paradym ICD and CRT-D Models 8250, 8550, and 8750.
P990025/S026
2/3/11
180-Day
NaviStar RMT Catheter (4mm)Biosense Webster Diamond Bar, CA 91765Approval for a manufacturing site located at Biosense Webster, Inc, Juarez, Mexico.
P000008/S017
2/16/11
Panel-Track
LAP-BAND™ Adjustable Gastric Banding SystemAllergan, Inc. Goleta, CA
93117
Approval for LAP-BAND™ Adjustable Gastric Banding System. The LAP-BAND™ System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m 2
or a BMI of at least 30 kg/ m 2 with one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.
P000009/S043
2/11/11
Real-Time
Estella DR ;
Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T;
Effecta D; Effecta DR; Effecta S; and Effecta SR
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The devices, as modified will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR.
P000018/S044
2/23/11
180-day
Beta-Cath™ SystemBest Vascular, Inc. Norcross, GA
30093
Approval of the post-approval study protocol.
P010013/S032
2/18/11
135-Day
NovaSure Impedance Controlled Endometrial Ablation SystemHologic, Inc.
Marlborough, MA
01752
Approval for a change to the molded manifold component to require the component to be annealed.
P010030/S024
2/18/11
Real-Time
LifeVest Wearable DefibrillatorsZoll Lifecor Corporation
Pittsburgh, PA
15238
Approval for software changes including asystole notification handling, low battery notification handling, and power up response button sequence in addition to labeling updates resulting from those changes.
P010032/S036
2/11/11
Real-Time
Eon Neurostimulation (IPG) SystemSt. Jude Medical
Plano, Texas
75024
Approval for adding heat shrink tubing to the conductors of the coaxial cable of the Charging Antenna which is used with the Eon IPG System.
P010032/S037
2/24/11
Real-Time
Eon Neurostimulation (IPG) SystemSt. Jude Medical
Plano, Texas
75024
Approval for antenna spacer disks for the Model 3701 Eon wall charger kit.
P010047/S001
2/17/11
180-Day
NeoMend ProGEL Pleural Air Leak SealantNeomend, Inc.
Irvine, CA
92618
Approval of the post-approval study protocol.
P010068/S021
2/3/11
180-Day
NaviStar RMT DS Catheter (8mm)Biosense Webster Diamond Bar, CA 91765Approval for a manufacturing site located at Biosense Webster, Inc, Juarez, Mexico.
P020014/S032
2/24/11
Real-Time
Conceptus Essure® System for Permanent Birth ControlConceptus, Inc. Mountain View, CA
94041
Approval for design changes to the duckbill valve of the valved introducer and changes to the length of the delivery wire.
P020026/S026
2/22/11
180-Day
4.00mm CYPHER® Sirolimus-Eluting Coronary Stent on RAPTORRAIL® Rapid Exchange (RX) Delivery SystemCordis Corporation Miami, FL
33102
Approval for the 4.0mm CYPHER® Sirolimus-eluting Coronary Stent on RAPTORRAIL® (RX) Delivery System. The device, as modified will be marketed under the trade name 4.00mm CYPHER® Sirolimus-eluting Coronary Stent on RAPTORRAIL® Rapid Exchange Delivery System and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length ≤ 30 mm in native coronary arteries with a reference vessel diameter of ≥ 2.25 to ≤ 4.0 mm.
P020036/S016
2/14/11
Real-Time
SMART Nitinol Stent System and SMART Control Nitinol Stent SystemCordis Corporation Bridgewater, NJ
08807
Approval for a change in colorant used in the catheters of the PRECISE and SMART Nitinol Stent Systems.
P020047/S023
2/3/11
135-Day
 
 
MULTI-LINK - 8™, MULTI-LINK - 8™ LL, and MULTI-LINK - 8™ SV Coronary Stent SystemsAbbott Vascular
Temecula, CA
92590
Approval for: 1) the addition of sensors for monitoring the coating process; and 2) minor tooling upgrades.
P030024/S014
2/28/11
135-Day
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and CalibratorOrtho Clinical Diagnostics, Inc. Cardiff, United KingdomApproval for a change in the manufacturing scale for a component reagent.
P030047/S019
2/14/11
Real-Time
PRECISE, PRECISE Rx, and PRECISE PRO Rx Nitinol Stent SystemsCordis Corporation Bridgewater, NJ
08807
Approval for a change in colorant used in the catheters of the PRECISE and SMART Nitinol Stent Systems.
P030054/S155
2/11/11
Real-Time
DSA0006 Slit Suture Sleeve AccessorySt. Jude Medical
Sylmar, CA
91342
Approval for a new 4.3-4.7 Fr slit suture sleeve accessory kit to be used with the approved 1258T Quickflex μ lead.
P040006/S005
2/8/11
Special
In Motion® Lumbar Artificial DiscDePuy Spine, Inc. Raynham, MA 02767Approval for the change in tolerance of the implant dimensions and the subsequent independent inspection of these dimensions.
P040043/S037
2/24/11
180-Day
GORE TAG Thoracic EndoprosthesisW.L. Gore and Associates, Inc. Flagstaff, AZ
86001
Approval to update the GORE TAG Thoracic Endoprosthesis instructions for use to include summary information on the evaluation of the physician training program for this device.
P040050/S007
2/4/11
180-Day
Macroplastique ImplantsUroplasty, Inc.
Minnetonka, MN
55343
Approval for a contract gamma sterilization site located at Steris/Isomedix Contract Sterilization Services, Libertyville, Illinois.
P050010/S008
2/16/11
Real-Time
ProDisc-L Total Disc ReplacementSynthes Spine
West Chester, PA
19380
Approval for MR Conditional Labeling.
P050023/S041
2/11/11
Real-Time
Estella DR ;
Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T;
Effecta D; Effecta DR; Effecta S; and Effecta SR
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The devices, as modified will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR.
P050034/S004
2/4/11
Real-Time
Implantable Miniature Telescopes™ (IMT)VisionCare Ophthalmic Technologies Saratoga, CA
95070
Approval for extending the shelf life of the IMT from 2 years to 3 years.
P050044/S016
2/4/11
Special
Vitagel Surgical HemostatOrthovita, Inc. Malvern, PA
19355
Approval for an additional in- process inspection of the Transfer Syringes to visually check that the caps are present and appropriately tightened.
P060019/S009
2/23/11
180-Day
Safire BLU and Therapy Cool Path Bi-Directional Ablation CathetersSt. Jude Medical Irvine, CA
92614
Approval to add bi-directional steering to the Therapy Cool Path Ablation Catheter. The devices, as modified, will be marketed under the trade names Safire BLU Irrigated Ablation Catheter and Therapy Cool Path Ablation Catheter.
P060027/S029
2/10/11
Real-Time
Paradym ICD and CRT-DELA Medical, Inc./ Sorin Group
Plymouth, MN
55441
Approval for changes to the transformer, Opto Wedge, and Desiccant for the Paradym ICD and CRT-D Models 8250, 8550, and 8750.
P070001/S009
2/16/11
Real-Time
ProDisc-C Total Disc ReplacementSynthes Spine
West Chester, PA
19380
Approval for MR Conditional Labeling.
P070008/S021
2/11/11
Real-Time
Estella DR ;
Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T;
Effecta D; Effecta DR; Effecta S; and Effecta SR
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The devices, as modified will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR.
P070015/S046
2/3/11
135-Day
XIENCE V® and PROMUS™ Everolimus Eluting Coronary Stent SystemsAbbott Vascular, Inc.
Temecula, CA
92591
Approval for changes to the testing plan for the drug substance.
P080013/S003
2/18/11
180-Day
DuraSeal Spine Sealant SystemCovidien
Bedford, MA
01730
Approval for the replacement of the current DuraSeal Spine Sealant polyethylene glycol (PEG) formulation with a lower molecular weight formulation.
P080015/S003
2/3/11
Real-Time
Cervista HPV 16/18Hologic, Inc.
Marlborough, MA 01752
Approval for several changes to the Cervista HPV 16/18 software and labeling. Changes include numerous user interface changes, and separating the Invader Call Reporter and Cervista HPV 16/18 software on to separate CDs with new part numbers.
P080027/S001
2/18/11
Panel-Track
OraQuick® HCV Rapid Antibody TestOraSure Technologies, Inc. Bethlehem, PA 18015Approval for the OraQuick® HCV Rapid Antibody Test. The device is a single-use immunoassay for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in fingerstick whole blood specimens and venipuncture whole blood specimens (EDTA, sodium heparin, lithium heparin, and sodium citrate) from individuals 15 years or older. The OraQuick® HCV Rapid Antibody Test results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HCV (state of infection or associated disease not determined) in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis C infection.
P080032/S004
2/4/11
180-Day
Alair Bronchial Thermoplasty SystemBoston Scientific Corporation
St. Paul, MN
55112
Approval for adding gamma irradiation as an alternative sterilization method, establishing expiration dating for that sterilization method, and adding Sterigenics (Hayward, California) as a contract sterilizer.
P090003/S005
2/3/11
135-Day
Express® LD Iliac Pre-mounted Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for multiple component-specific manufacturing process changes.
P090006/S002
2/15/11
180-Day
Complete SE Vascular Stent SystemMedtronic Vascular Santa Rosa, CA
95403
Approval for the 120mm length Complete SE Vascular Stent.
P090022/S004
2/2/11
Real-Time
Softec HD PS Posterior Chamber Intraocular Lens (PCIOL)Lenstec, Inc.
St. Petersburg, FL 33716
Approval to extend the power range for which lenses are marketed in 1/4 diopter increment from 18.0 through 25.0 diopters to 15.0 through 25.0 diopters. The device, as modified, will be marketed under the trade name Softec HD PS Posterior Chamber Intraocular Lens (PCIOL) and is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. The lens is indicated for capsular bag placement.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N16895/S092
2/9/11
Bausch & Lomb SofLens (polymacon) Visibility Tinted Contact LensesBausch & Lomb, Inc.
Rochester, NY
14609
Change in supplier location.
N18033/S051
2/14/11
VISTAKON® (etafilcon A) Soft Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Implementation of an alternate test method for determining the purity in the raw material, N,N-Dimethyacrylamide, used in the VISTAKON® (etafilcon A) Soft Contact Lenses.
N18033/S052
2/14/11
VISTAKON® (etafilcon A) Soft Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Implementation of an automated process for verifying lot data prior to printing labels for VISTAKON® (etafilcon A) Contact Lenses.
N18033/S053
2/14/11
VISTAKON® (etafilcon A) Soft Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Implementation of an alternate test method for determining the purity in the raw material, Methacrylic Acid, used in the VISTAKON® (etafilcon A) Soft Contact Lenses.
P810002/S072
2/7/11
St. Jude Medical Mechanical Heart ValveSt. Jude Medical
St. Paul, MN
55117
Change in gel fixation time.
P880086/S197
2/23/11
Affinity, Integrity, Victory, Zephyr, and Accent Families of PacemakersSt. Jude Medical, Inc.
Sylmar, CA
91342
Change to the setscrew and septum installation process.
P890003/S212
2/24/11
Prodigy Family of IPGsMedtronic, Inc.
Mounds View, MN
55112
Revision of parameters to an epoxy dispense manufacturing process.
P910001/S043
2/3/11
 
ELCA Coronary Atherectomy CathetersSpectranetics Corporation
Colorado Springs, CO
80921
Use of additional pouch sealing equipment.
P910001/S044
2/28/11
 
ELCA Coronary Atherectomy CathetersSpectranetics Corporation
Colorado Springs, CO
80921
Modifications to the glass preform process.
P930038/S065
2/18/11
Angio-Seal™ Vascular Closure DeviceSt. Jude Medical
St. Paul, MN
55117
Reduction in the frequency of an in- process quality control inspection.
P950022/S076
2/10/11
Durata Family of LeadsSt. Jude Medical Sylmar, CA
91342
Use of an alternate supplier for a lead component.
P950032/S062
2/10/11
ApligrafOrganogenesis, Inc. Canton, MA
02021
Alternate supplier for the polycarbonate base film used in the manufacture of a culture insert.
P960042/S025
2/9/11
Spectranetics Laser Sheath II (SLS II)Spectranetics Corporation
Colorado Springs, CO
80921
Change to the fusing process for the outer jacket tubing.
P960042/S026
2/28/11
 
Spectranetics Laser Sheath II (SLS II)Spectranetics Corporation
Colorado Springs, CO
80921
Modifications to the glass preform process.
P970003/S120
2/17/11
VNS Therapy® SystemCyberonics, Inc.
Houston, TX
77058
Addition of alternate raw materials and removal of associated cleaning steps.
P970003/S121
2/28/11
VNS Therapy® SystemCyberonics, Inc.
Houston, TX
77058
Change to the pulse generator manufacturing process.
P970012/S082
2/24/11
Kappa 400 Family of IPGsMedtronic, Inc.
Mounds View, MN
55112
Revision of parameters to an epoxy dispense manufacturing process.
P970021/S032
2/16/11
 
Gynecare Thermachoice III Uterine Balloon Therapy SystemETHICON, Inc. Somerville, NJ
08876
Use of a new sub- tier supplier for the printed circuit board assembly.
P970021/S033
2/25/11
Gynecare Thermachoice III Uterine Balloon Therapy SystemETHICON, Inc.
Somerville, NJ
08876
Change in the cleaning solution used in removing residue from the heating wire during the manufacturing process.
P980016/S274
2/3/11
Virtuoso, Secura DR/VR, Maximo II DR/VR, and Virtuoso II VR/DR ICDsMedtronic, Inc.
Mounds View, MN
55112
Reduction in the frequency of a quality control test for the Laser Ribbon Bonding (LRB) process.
P980016/S275
2/10/11
Maximo II DR /VR, Virtuoso II DR/VR and Secura DR/VRMedtronic, Inc. Mounds View, MN 55112Updates to test software used during final functional device testing.
P980016/S276
2/17/11
Maximo II DR /VR, Virtuoso II DR/VR, Secura DR/VR, Virtuoso, EnTrust, Marquis, Maximo and Intrinsic Families of ICDsMedtronic, Inc. Mounds View, MN 55112Implementation of a detection step in the battery manufacturing process at a supplier.
P980016/S277
2/24/11
Entrust, Intrinsic, Marquis, Maximo, Maximo II, Secura, Virtuoso and Virtuoso II Families of ICDsMedtronic, Inc.
Mounds View, MN
55112
Revision of parameters to an epoxy dispense manufacturing process.
P980016/S279
2/23/11
Entrust ICD, Intrinsic, Marquis, Maximo, Maximo ICD, Maximo II DR/VR, Secura DR/VR ICD, Virtuoso ICD, Virtuoso II DR/VR ICDMedtronic, Inc. Mounds View, MN 55112Automation of an additional plating line.
P980018/S012
2/11/11
HercepTest™Dako Denmark A/S Glostrup, DenmarkAutomated filling of DAB chromogen for HercepTest™ as the primary filling process.
P980035/S201
2/24/11
Medtronic 350 Series, Adapta, AT500, EnPulse, EnRhythm, Kappa 700/800/900, Relia, Sensia, Sigma, and Versa Families of IPGsMedtronic, Inc.
Mounds View, MN
55112
Revision of parameters to an epoxy dispense manufacturing process.
P980035/S202
2/23/11
Adapta, Versa, Sensia, EnRhythm, Relia IPGsMedtronic, Inc. Mounds View, MN 55112Automation of an additional plating line.
P990001/S083
2/24/11
Vitatron DA+ C-Series and DA+ T-Series Families of IPGsMedtronic, Inc.
Mounds View, MN
55112
Revision of parameters to an epoxy dispense manufacturing process.
P990001/S084
2/23/11
Vitatron DA+ C-Series, and
DA+ T-Series Families of IPGs
Medtronic, Inc. Mounds View, MN 55112Automation of an additional plating line.
P990020/S044
2/7/11
AneuRX AAAdvantage Stent Graft SystemMedtronic Vascular
Santa Rosa, CA
95403
Change to sample numbers for Endotoxin Testing and a lot definition change.
P000037/S022
2/16/11
On-X® Prosthetic Heart ValveOn-X Life Technologies, Inc.Added production capability for two currently outsourced machining processes.
P000039/S039
2/18/11
AMPLATZER® Septal OccluderAGA Medical Corporation
Plymouth, MN
55442
Use of new patch forming equipment.
P010001/S008
2/25/11
Ceramic TRANSCEND® Hip Articulation SystemCeramTec GmbH
Plochingen, Germany
Addition of two “like to like” machines used for the following manufacturing processes of the ceramic ball heads: 1) grinding the inner bore and chamfer; and 2) polishing the outer ball head contour.
P010015/S108
2/24/11
InSync and InSync III Families of CRT-PsMedtronic, Inc.
Mounds View, MN
55112
Revision of parameters to an epoxy dispense manufacturing process.
P010031/S229
2/3/11
Consulta, Consulta II, Maximo II and Concerto CRT-DsMedtronic, Inc.
Mounds View, MN 55112
Reduction in the frequency of a quality control test for the Laser Ribbon Bonding (LRB) process.
P010031/S230
2/10/11
Concerto II CRT-D, Maximo II CRT-D, and Consulta CRT-DMedtronic, Inc.
Mounds View, MN 55112
Updates to test software used during final functional device testing.
P010031/S231
2/17/11
Concerto II, Maximo II, Consulta, Concerto, InSync Maximo, InSync Sentry, InSync II Marquis, and InSync III Marquis Families of CRT-DsMedtronic, Inc. Mounds View, MN 55112Implementation of a detection step in the battery manufacturing process at a supplier.
P010031/S233
2/24/11
Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry and Maximo II Families of CRT-DsMedtronic, Inc.
Mounds View, MN
55112
Revision of parameters to an epoxy dispense manufacturing process.
P010031/S235
2/23/11
Concerto CRT-D, Concerto II ICD, Consulta CRT-D, InSync II Marquis, InSync II Protect, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II CRT-DMedtronic, Inc. Mounds View, MN 55112Automation of an additional plating line.
P010047/S008
2/10/11
NeoMend ProGel™ Surgical SealantNeoMend, Inc. Irvine, CA
92618
Packaging of ProGel™ Applicator Spray Tips as an accessory separately from the NeoMend Pleural Air Leak Sealant Device.
P020004/S058
2/18/11
GORE® EXCLUDER® AAA EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Automation for crimping gold marker bands.
P020024/S031
2/18/11
AMPLATZER® Duct Occluder, AMPLATZER® 1800 Delivery and Exchange SystemAGA Medical Corporation
Plymouth, MN
55442
Use of new patch forming equipment.
P020056/S013
2/11/11
Natrelle Silicone-Filled Breast ImplantsAllergan
Goleta, CA
93117
Change in the tubing used in the gel filling process.
P030011/S010
2/18/11
SynCardia Temporary Total Artificial Heart (TAH-t) SystemSynCardia Systems, Inc.
Tuscon, AZ
85713
Relocation of several critical manufacturing operations from one building to another within the same corporate complex.
P030035/S077
2/23/11
Frontier, Frontier II, and Anthem Families of CRT-PsSt. Jude Medical, Inc.
Sylmar, CA
91342
Change to the setscrew and septum installation process.
P040014/S016
2/17/11
Therapy Cardiac Ablation CatheterSt. Jude Medical, Inc.
Irvine, CA
92614
Implementation of an additional test system for electrical testing.
P040037/S034
2/16/11
Gore VIBAHN® EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AR
86001
Duplication of a manufacturing process at an alternate building within the same complex.
P040037/S035
2/18/11
Gore VIABAHN® EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AR
86001
Duplication of a similar manufacturing process at an alternate location.
P040040/S016
2/18/11
Amplatzer® Muscular VSD OccluderAGA Medical Corporation
Plymouth, MN
55442
Use of new patch forming equipment.
P040042/S021
2/17/11
Therapy Dual 8, Therapy and Safire TX Ablation CathetersSt. Jude Medical, Inc.
Irvine, CA
92614
Implementation of an additional test system for electrical testing.
P050006/S019
2/18/11
GORE® HELEX Septal OccluderW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Addition of alternate powder for the manufacturing of the Occluder.
P050028/S013
2/24/11
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 for use with The High Pure SystemRoche Molecular Systems, Inc.
Pleasanton, CA
94566
Elimination of the in-process chemical testing of the Buffer Concentrate component of the Master Mix used with the COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 within the FDA approved PCR Manufacturing Center (PMC) facility in Branchburg, New Jersey.
P050042/S009
2/17/11
ARCHITECT Anti-HCVAbbott Laboratories Abbott Park, IL
60064
Change in the vendors for antifoam and goat serum, and a change in a material test method.
P050044/S017
2/25/11
Vitagel Surgical HemostatOrthovita Incorporated
Malvern, PA
19355
Addition of an alternate location for conducting two microbiological assays used in the manufacture of the Vitagel Surgical Hemostat.
P060002/S017
2/16/11
FLAIR® Endovascular Stent GraftC.R. Bard, Inc. Tempe, AZ
85281
Changes to the manufacturing data access and storage software systems.
P060019/S017
2/17/11
Therapy Cool Path Ablation CatheterSt. Jude Medical, Inc.
Irvine, CA
92614
Implementation of an additional test system for electrical testing.
P060030/S15
2/24/11
COBAS TaqMan HCV Test, v2.0 for use with The High Pure SystemRoche Molecular Systems, Inc.
Pleasanton, CA
94566
Elimination of the in-process chemical testing of the Buffer Concentrate component of the Master Mix used with the COBAS TaqMan HCV Test, v2.0.
P060038/S009
2/3/11
Mitroflow® Aortic Pericardial Heart ValveSorin Group USA, Inc.
Arvada, CO
80004
Addition of a supplier of a device component.
P070007/S027
2/7/11
Talent Thoracic Stent Graft SystemMedtronic Vascular
Santa Rosa, CA
95403
Change to sample numbers for Endotoxin Testing and a lot definition change.
P070022/S010
2/16/11
Adiana Permanent Contraception SystemGYN-Surgical Products
Marlborough, MA
01752
Change to the work instructions for the fluid filling process of the damper subassembly.
P070027/S028
2/7/11
Abdominal Stent Graft SystemMedtronic Vascular
Santa Rosa, CA
95403
Change to sample numbers for Endotoxin Testing and a lot definition change.
P100021/S001
2/7/11
Endurant Stent Graft SystemMedtronic Vascular
Santa Rosa, CA
95403
Change to sample numbers for Endotoxin Testing and a lot definition change.

Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 53

Summary of PMA Originals Under Review
Total Under Review: 97
Total Active: 49
Total On Hold: 48
Number Greater Than 180 Days: 5

Summary of PMA Supplements Under Review
Total Under Review: 682
Total Active: 474
Total On Hold: 208
Number Greater Than 180 Days: 12

Summary of All PMA Submissions Received
Originals: 4
Supplements: 82

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 53
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 171.8
FDA Time: 110.4 Days MFR Time: 61.4 Days