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U.S. Department of Health and Human Services

Medical Devices

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July 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
P100001
7/20/11
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, VITROS Immunodiagnostic Products Anti-HBe Calibrator, VITROS Immunodiagnostic Products Anti-HBe ControlsOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Approval for the VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, Calibrator and Controls. This device is indicated for:
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack - For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy.
VITROS Immunodiagnostic Products Anti-HBe Calibrator - For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems when used
with the VITROS Anti-HBe test for the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe). VITROS Immunodiagnostic Products Anti-HBe Controls - For use in monitoring the performance of the VITROS Anti-HBe test when used on the VITROS ECi/ECiQ Immunodiagnostic Systems.
P110001
7/20/11
RX Herculink Elite Renal Stent SystemAbbott Vascular
Temecula, CA
92592
Approval for the RX Herculink Elite Renal Stent System. This device is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (PTRA) of a de novo or restenotic atherosclerotic lesion (≤ 15 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0 - 7.0 mm. Suboptimal PTRA is defined as ≥ 50% residual stenosis, ≥ 20 mmHg peak systolic or ≥ 10 mmHg mean translesional pressure gradient, flow-limiting dissection, or TIMI [Thrombolysis In Myocardial Infarction] flow < 3.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N18286/S021
7/9/11
Real-Time
Gelfoam (absorbable gelatin) Sterile SpongePfizer, Inc.
New York, NY
10017
Approval for a change in some of the components contained in the Gelfoam Plus Kit as well as the introduction of an alternative Gelfoam Plus Kit – Gelfoam Plus compressed. The component changes will substitute prefilled saline syringes and a needleless transfer device for the standard saline vials and needle-syringe. The components have been cleared/ approved previously. The purpose of the Gelfoam Plus Kit is to provide the convenience of co-packaged collagen sponge, saline diluent and Human Thrombin to a physician during surgery.
P810002/S074
7/18/11
135-Day
Masters Valved GraftSt. Jude Medical, Inc.Approval for change to the sterilization load and configuration.
P830055/S118
7/1/11
135-Day
LCS Total Knee SystemDePuy Orthopedics, Inc.
Warsaw, IN
46581
Approval for a change to a new drag finishing process at the Cork, Ireland facility.
P860003/S057
7/29/11
180-Day
THERAKOS CELLEX Photopheresis SystemTherakos, Inc.
Raritan, NJ
08869
Approval for software changes to the THERAKOS CELLEX Photopheresis System.
P860004/S123
7/29/10
Real-Time
The Guidewire Accessory for Intrathecal CathetersMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for the Changes to the Guidewire Accessory for Intrathecal Catheter Models 8731SC and 8598A.
P860004/S130
7/1/11
180-Day
The Battery for the SynchroMed IIMedtronic Neuromodulation Minneapolis, MN 55432Approval for design changes to the Battery for the SynchroMed II Model 8637 Programmable Drug Infusion System.
P860057/S071
7/26/11
180-Day
Carpentier-Edwards Magna Mitral Pericardial BioprosthesisEdwards Lifesciences, LLC
Irvine, CA
92614
Approval of the post-approval study protocol.
P860057/S072
7/27/11
135-Day
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthetic ValvesEdwards Lifesciences, LLC Irvine, CA
92614
Approval for an alternate supplier for Atex Bias Cloth.
P870056/S040
7/27/11
135-Day
Carpentier-Edwards Porcine Bioprosthetic ValvesEdwards Lifesciences, LLC Irvine, CA
92614
Approval for an alternate supplier for Atex Bias Cloth.
P880086/S193
7/25/11
180-Day
Affinity/Integrity/ Victory/Verity/ Zephyr and Accent Family of PacemakersSt. Jude Medical Sunnyvale, CA
94086
Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P880086/S205
7/22/11
Real-Time
Sustain XL Family of PacemakersSt. Jude Medical, Inc.
Sunnyvale, CA
94086
Approval for a change to the seal plug for the setscrew (referred to as the septum in the submission).
P890003/S226
7/1/11
Real-Time
Consulta CRT-P and Syncra CRT-P Implantable DevicesMedtronic, Inc. Mounds View, MN 55112Approval of modification to the “2490G Software Requirements Specification” to add the CRT-P device model numbers to the Auto-ID list for the Model 2020A CardioSight Reader.
P910001/S045
7/14/11
135-Day
ELCA Coronary Atherectomy CathetersSpectranetics Corporation
Colorado Springs, CO
80921
Approval for changes to pyrogen testing procedures and sampling.
P910007/S021
7/26/11
180-Day
ARCHITECT Total PSAAbbott Laboratories Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd in Singapore.
P910007/S029
7/22/11
180-Day
ARCHITECT Total PSAAbbott Laboratories
Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P920047/S046
7/27/11
135-Day
Blazer II & Blazer Prime HTD CathetersBoston Scientific Corporation
San Jose, CA
95134
Approval for an alternate sterilization cycle.
P920047/S047
7/19/11
180-Day
Blazer II/Prime HTD CathetersBoston Scientific Corporation
San Jose, CA
95134
Approval for packaging design change for the Blazer II/Prime HTD Catheters – Electrophysiology Cables, Models M0046130 and M0046510; Chilli® Cooled Ablation System – Electrophysiology Cables, Models M0046810 and M004620620; and Blazer II XP and Blazer Prime Cardiac Ablation Catheters – Electrophysiology Cables, Models M0046130 and M0046510.
P930031/S029
7/19/11
135-Day
Wallstent® TIPS Endoprosthesis with Unistep™ Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for a component vendor facility site change.
P940019/S024
7/19/11
135-Day
Wallstent® Iliac Endoprosthesis with Unistep™ Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for a component vendor facility site change.
P950022/S074
7/25/11
180-Day
Passive Fixation sj4 LeadsSt. Jude Medical Sunnyvale, CA
94086
Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P950024/S017
7/29/11
180-Day
CapSure EPI Unipolar and Bipolar LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Co. in Villalba, Puerto Rico.
P950037/S062
7/1/11
135-Day
Selox SR/St/JT, Setrox S and Dextrus Steroid-Eluting LeadsBiotronik, Inc.
Lake Oswego, OR
97035
Approval for a second manufacturer of the steroid collar, and second source of dexamethasone acetate (DXA) used for production of the steroid collar.
P960013/S062
7/25/11
180-Day
Tendril, Tendril ST, Tendril STS and Optisense LeadsSt. Jude Medical Sunnyvale, CA
94086
Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P960030/S032
7/25/11
180-Day
Passive Plus, Isofles S&P and Isoflex Optim LeadsSt. Jude Medical Sunnyvale, CA
94086
Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P960042/S027
7/14/11
135-Day
Spectranetics Laser Sheath IISpectranetics Corporation
Colorado Springs, CO
80921
Approval for changes to pyrogen testing procedures and sampling.
P970003/S130
7/29/11
Real-Time
VNS Therapy System – Programming SoftwareCyberonics, Inc.
Houston, TX
77058
Approval for a modification to the Serial Adapter Cable Power Connector.
P970013/S036
7/25/11
180-Day
Microny Family of PacemakersSt. Jude Medical Sunnyvale, CA
94086
Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P970018/S023
7/15/11
Special
BD Prepstain SystemTripath Imaging Inc. (dba BD Diagnostics)
Durham, NC
27703
Approval for vacuum pump safety hazard labeling changes.
P980003/S028
7/27/11
135-Day
Chilli II CathetersBoston Scientific Corporation
San Jose, CA
95134
Approval for an alternate sterilization cycle.
P980003/S029
7/19/11
Real-Time
Chilli® Cooled Ablation System – Electrophysiology CablesBoston Scientific Corporation
San Jose, CA
95134
Approval for packaging design change for the Blazer II/Prime HTD Catheters – Electrophysiology Cables, Models M0046130 and M0046510; Chilli® Cooled Ablation System – Electrophysiology Cables, Models M0046810 and M004620620; and Blazer II XP and Blazer Prime Cardiac Ablation Catheters – Electrophysiology Cables, Models M0046130 and M0046510.
P980007/S013
7/26/11
180-Day
ARCHITECT Free PSAAbbott Laboratories Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd in Singapore.
P980007/S020
7/22/11
180-Day
ARCHITECT Free PSAAbbott Laboratories
Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P980023/S034
7/1/11
135-Day
Kentrox SL/SL-S/RV/RV-S and Linox S/SD/T/TD Steroid-Eluting LeadsBiotronik, Inc.
Lake Oswego, OR
97035
Approval for a second manufacturer of the steroid collar, and second source of dexamethasone acetate (DXA) used for production of the steroid collar.
P980033/S018
7/19/11
135-Day
Wallstent® Venous Endoprosthesis with Unistep™ Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for a component vendor facility site change.
P980037/S036
7/19/11
Real-Time
AngioJet® Rheolytic™ Thrombectomy SystemMEDRAD Interventional/
Possis
Minneapolis, MN
55433
Approval for modifications to the Ultra Console to make it more robust to fluid ingress.
P980041/S013
7/1/11
180-Day
Access AFP Assay On the Access® Immunoassay SystemsBeckman Coulter, Inc.
Chaska, MN
55318
Approval for the following modifications made to the Access, Synchron and UniCel families of instrumentation platforms: 1) modification of the occlusion bracket on the Access and UniCel instruments; 2) revision of the UniCel system software; 3) redesign of the sample probe tube assembly; and 4) new information regarding potential interferents of AFP measurement due to the presence of immunosuppressant drugs prescribed to pregnant women.
P990019/S007
7/7/11
Real-Time
BLU-U® Blue Light Photodynamic Therapy IlluminatorDUSA
Pharmaceuticals, Inc.
Wilmington, MA
01887
Approval for a software change to eliminate the need to artificially limit the cycle lifetime for the BLU-U treatment lamp system.
P000007/S025
7/27/11
135-Day
Edwards Porcine Stentless Bioprosthetic ValveEdwards Lifesciences, LLC Irvine, CA
92614
Approval for an alternate supplier for Atex Bias Cloth.
P000008/S024
7/29/11
Special
LAP-BAND® Adjustable Gastric Banding (LAGB) SystemAllergan
Goleta, CA
93117
Approval to modify the Directions for Use for the RapidPort EZ Port Applier, an accessory to the LAP-BAND System, to clarify the proper method of holding the RapidPort EZ Port Applier and how to apply pressure to the Port Applier to ensure the correct positioning of the access port.
P000025/S050
7/22/11
180-Day
MED-EL COMBI 40+ Cochlear Implant SystemMED-EL Corporation
Durham, NC
27713
Approval for an updated version of the MED-EL COMBI 40+ Cochlear Implant System referred to as MAESTRO 2010 consisting of the following features:
1) a thinner version of the SONATATi- 100 cochlear implant, the Mi1000 MED-EL CONCERT;
2) several design and manufacturing updates related to the introduction of the Mi1000 MEDEL CONCERT; 3) new tasks and functionalities added to the MAESTRO fitting software in MAESTRO 4.0;
4) a selection of new colors available for the OPUS 2 audio processor and; 5) a new, more energy-efficient, audio processor coil called D-Coil.
P000025/S052
7/22/11
Real-Time
Combi 40+ Cochlear Implant SystemMED-EL Corporation
Durham, NC
27713
Approval for introduction of the Mini Battery Pack, an optional external battery pack to be used to power the TEMPO+, OPUS 1, and OPUS2 audio processors.
P010014/S031
7/29/11
Real-Time
Oxford® Partial Knee SystemBiomet, Inc.Approval for labeling changes to the surgical technique brochure for the Oxford® Partial Knee System that include the addition of instructions for use for the Signature™ Personalized Patient Care System (patient-matched cutting/drilling guides.)
P010015/S125
7/1/11
Real-Time
Consulta CRT-P and Syncra CRT-P Implantable DevicesMedtronic, Inc. Mounds View, MN 55112Approval of modification to the “2490G Software Requirements Specification” to add the CRT-P device model numbers to the Auto-ID list for the Model 2020A CardioSight Reader.
P010023/S009
7/15/11
135-Day
MAXUM SystemOtotronix, LLC
St. Paul, MN
55110
Approval of a manufacturing process and supplier change to the Magnet Canister Assembly.
P010030/S027
7/15/11
Real-Time
WCD 3000,
WCD 3000S,
WCD 3100 and WCD 4000
Zoll Lifecor Corporation
Pittsburgh, PA 15238
Approval for the minor hardware (components) changes due to the RoHS requirements for the components of the devices.
P010030/S028
7/7/11
Real-Time
LifeVest® Wearable DefibrillatorZoll Lifecor Corporation
Pittsburgh, PA
15238
Approval for use of the E-One Moli Energy IHR18650B (2.25Ah) Lithium-Ion battery cell with your LifeVest® Model 4000 Wearable Defibrillator.
P020014/S034
7/1/11
180-Day
Conceptus Essure® System for Permanent Birth ControlConceptus, Inc.
Mountain View, CA
94041
Approval to remove a contraindication and to revise a warning regarding nickel sensitivity in physician’s labeling.
P020025/S027
7/27/11
135-Day
Blazer II XP and Blazer Prime XP CathetersBoston Scientific Corporation
San Jose, CA
95134
Approval for an alternate sterilization cycle.
P020025/S028
7/19/11
Real-Time
Blazer II XP and Blazer Prime Cardiac Ablation Catheters – Electrophysiology CablesBoston Scientific Corporation
San Jose, CA
95134
Approval for packaging design change for the Blazer II/Prime HTD Catheters – Electrophysiology Cables, Models M0046130 and M0046510; Chilli® Cooled Ablation System – Electrophysiology Cables, Models M0046810 and M004620620; and Blazer II XP and Blazer Prime Cardiac Ablation Catheters – Electrophysiology Cables, Models M0046130 and M0046510.
P020045/S037
7/15/11
Real-Time
Freezor Cardiac CryoAblation Catheters, Freezor Xtra and Freezor MAX Surgical CryoAblation Devices and CCT.2 CryoConsole SystemMedtronic CryoCath LP
Quebec, Canada
Approval for sterilization and packaging changes.
P030025/S093
7/25/11
180-Day
TAXUS ® Express 2® Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire)Boston Scientific Corporation
Maple Grove, Mn 55311
Approval for labeling changes to update the directions for use to include additional data from the TAXUS VISR study.
P030032/S012
7/18/11
Real-Time
PREVELLE SilkGenzyme Biosurgery
Cambridge, MA
02142
Approval for changes in the methods and specifications for testing the PREVELLE Silk final product (i.e., 1) changing the "Average Extrusion Force" specification
from less than 80N to an "Average of Average Extrusion Force" specification of less than 40N;
2) changing the "Maximum Peak Extrusion Force" specification of less than 100N to an
"Average of Maximum Peak Extrusion Force" specification of less than 50N; and 3) changing the
method of determining the "Maximum Peak Extrusion Force" specification from the highest single value observed in 10 samples to an "Average of the Maximum Peak Extrusion Force" test
results observed in 25 samples).
P030035/S073
7/25/11
180-Day
Frontier/Frontier II Family of CRT-PSSt. Jude Medical Sunnyvale, CA
94086
Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P030035/S085
7/22/11
Real-Time
Promote/Frontier Family of PacemakersSt. Jude Medical, Inc.
Sunnyvale, CA
94086
Approval for a change to the seal plug for the setscrew (referred to as the septum in the submission).
P030054/S168
7/25/11
180-Day
Epic HF/Atlas+ HF Family of CRT-DSSt. Jude Medical Sunnyvale, CA
94086
Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P040012/S036
7/28/11
135-Day
Acculink Carotid Stent SystemAbbott Vascular, Inc.
Santa Clara, CA
95054
Approval for changes to your solution manufacturing process.
P040024/S050
7/1/11
135-Day
Restylane Injectable GelMedicis Pharmaceutical CorporationApproval for a change in the composition of the biological indicator used for qualification and requalification of the steam sterilization procedure.
P040024/S052
7/18/11
180-Day
Restylane Injectable GelMedicis Aesthetics Holding, Inc.
Scottsdale, AZ
85256
Approval for an extension to the expiration date of the lidocaine hydrochloride raw material from 12 months to 24 months.
P040044/S038
7/21/11
180-Day
Mynx Vascular Closure Device FamilyAccess Closure, Inc. Mountain View, CA 94043Approval for a contract sterilization site, BeamOne, LLC located in Mountain View, California
P050017/S006
7/5/11
180-Day
6Fr Zilver Flex™ Vascular StentCook Incorporated Bloomington, IN 47404Approval for a product line extension that represents modifications to the 6Fr version of the Zilver Vascular Stent. In addition, approval of minor changes to the stent and delivery system and the addition of a 100 mm length stent. The device, as modified, will be marketed under the trade name Zilver Flex™ 35 Vascular Stent and is
indicated for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 9 mm. Patients must be suitable for PTA and stent treatment.
P050023/S014
7/1/11
135-Day
Corox OTW UP Steroid-Eluting LeadBiotronik, Inc.
Lake Oswego, OR
97035
Approval for a second manufacturer of the steroid collar, and second source of dexamethasone acetate (DXA) used for production of the steroid collar.
P050028/S017
7/7/11
135-Day
COBAS AmpliPrep/COBAS TaqMan HBV Test, v.2.0
 
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for changes to in-process testing procedures for the Elution Buffer and Manganese Reagent to be implemented at the manufacturing site in Somerville, New Jersey.
P050040/S001
7/12/11
180-Day
SPOT-Light® HER2 CISH™ KitLife Technologies Corporation
Frederick, MD
21704
Approval for a manufacturing site located in Frederick, Maryland.
P050042/S007
7/20/11
180-Day
ARCHITECT Anti-HCVAbbott Laboratories Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd. in Singapore.
P050043/S005
7/11/11
Real-Time
FISH-SP™ Advanced Compression DeviceMorris Innovative Research, Inc.
Bloomington, IN
47403
Approval for: adding a cuff stabilizer sheath, modifying the suture indicator knots and updating labeling. The device, as modified, will be marketed under the trade name FISH- SP™ Advanced Compression Device and is indicated for "...for hemostatic
closure of femoral artery access sites. The system is indicated for use in reducing time to
hemostasis and time to ambulation in patients who have undergone diagnostic procedures using
5, 6, 7 or 8 French procedural sheaths."
P050051/S006
7/20/11
180-Day
ARCHITECT AUSABAbbott Laboratories Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd. in Singapore.
P060007/S005
7/20/11
180-Day
ARCHITECT HBsAg and ARCHITECT HBsAg ConfirmatoryAbbott Laboratories Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd. in Singapore.
P060010/S010
7/28/11
Real-time
The Spanner™ Temporary Prostatic StentAbbeyMoor Medical, Inc.
Parkers Prairie, MN
56361
Approval for a design change to add an access tether, called the Shore Line to the device.
P060035/S003
7/20/11
180-Day
ARCHITECT CORE-MAbbott Laboratories Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd. in Singapore.
P070008/S004
7/1/11
135-Day
Corox OTW (-S) BP Steroid-Eluting LeadBiotronik, Inc.
Lake Oswego, OR
97035
Approval for a second manufacturer of the steroid collar, and second source of dexamethasone acetate (DXA) used for production of the steroid collar.
P070009/S011
7/15/11
180-Day
REALIZE® Pressure Recording SystemEthicon Endo-Surgery, Inc. Cincinnati, OH 45242Approval for the REALIZE® Pressure Recording System, indicated to record and display fluid pressure variations within a closed system by converting mechanical inputs to analog/digital electrical signals.
P070022/S013
7/5/11
135-Day
 
Adiana Permanent Contraception SystemHologic, Inc.
Marlborough, MA
01752
Approval for minor changes to a damper test fixture and revision of the damper assembly process.
P080023/S003
7/20/11
180-Day
ARCHITECT COREAbbott Laboratories Irving, TX
75038
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd. in Singapore.
P080027/S005
7/27/11
135-Day
OraQuick® HCV Rapid Antibody TestOraSure Technologies, Inc.
Bethlehem, PA
18015
Approval for the option to automate the manufacturing process for assembly of the OraQuick® HCV Rapid Antibody Test.
P090018/S009
7/7/11
Real-Time
 
Esteem®Envoy Medical Corporation
St. Paul, MN
55110
Approval for the user interface software change to the Esteem Commander Programmer.
P100010/S008
7/15/11
Real-Time
Arctic Front® Cardiac Cryoablation CatheterMedtronic CryoCath LP
Quebec, Canada
Approval for sterilization and packaging changes.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P810031/S039
7/21/11
Healon 10mg/ml, Healon GV 14mg/ml, Healon 5 23mg/mlAbbott Medical Optics, Incorporated
Santa Ana, CA
92705
Change the test method for bioburden testing of finished product prior to moist heat sterilization.
 
P810032/S060
7/21/11
PMMA Multi-Piece Posterior Chamber Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Change from a manual proof-reading process to an automated proof-reading system.
P820003/S107
7/7/11
EPG Safety Cable and Disposable CoverMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P820003/S108
7/21/11
Plastic Cover for 5388 EPG, EPG Safety Cable and Safety ECG Electrode used with 6074 and 6074L Patient CablesMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P830061/S067
7/7/11
CapSure, Vitatron Crystaline, Vitatron Excellence+ and Vitatron Excellence PS+ LeadsMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P830061/S068
7/27/11
CapSure, Vitatron Crystaline, Vitatron Excellence PS+ LeadsMedtronic, Inc.
Mounds View, MN
55112
Addition of second supplier of silicone tubing.
P830061/S069
7/21/11
CapSure, Vitatron Crystalline, Vitatron Excellence + and Vitatron Excellence PS+ Families of LeadsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P840001/S189
7/6/11
Restore Family of Implantable NeurostimulatorsMedtronic Neuromodulation Minneapolis, MN
55432
Updating the welding equipment software at a vendor.
P840001/S190
7/7/11
Restore Family of Implantable Neurostimulators/ Itrel/Synergy Family of INS/SymMix Surgical LeadMedtronic Neuromodulation Minneapolis, MN 55432Update statistical process control software.
P840001/S191
7/29/11
Intrel 3, Restore, SymMix, Pisces, Synergy FamilyMedtronic Neuromodulation
Minneapolis, MN
55432
Procedure modification to meet the requirements of updated industry standards.
P840060/S037
7/21/11
PMMA Single-Piece Posterior Chamber Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Change from a manual proof-reading process to an automated proof-reading system.
P850051/S075
7/7/11
Vitatron Legacy IPGMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P850051/S076
7/21/11
Vitatron Legacy Family of IPGsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P850089/S079
7/7/11
CapSure, CapSure SP, CapSure Z Novus, Vitatron Excellence S+,
Vitatron Excellence SS+, Vitatron Impulse and Vitatron Impulse
II Leads
Medtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P850089/S080
7/27/11
CapSure, CapSure Z Novus, Vitatron Excellence SS+, Vitatron Impulse II LeadsMedtronic, Inc.
Mounds View, MN
55112
Addition of second supplier of silicone tubing.
P850089/S081
7/21/11
CapSure, CapSure Z Novus, CapSure SP Z, Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse and Vitatron Impulse II Families of LeadsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P860004/S153
7/7/11
SynchroMed II Implantable Infusion Pump/InDura 1P Intrathecal Catheters/Intrathecal CatheterMedtronic Neuromodulation Minneapolis, MN 55432Update statistical process control software.
P860004/S154
7/29/11
Synchromed Pumps, Indura Family Catheters, Intraspinal Trial KitsMedtronic Neuromodulation
Minneapolis, MN
55432
Procedure modification to meet the requirements of updated industry standards.
P880087/S019
7/21/11
PMMA Single- Piece Anterior Chamber Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Change from a manual proof-reading process to an automated proof-reading system.
P890003/S230
7/7/11
CapSure Leads and Prodigy IPG w/Associated Kits, Cables and Port Pin PlugsMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P890003/S231
7/21/11
Capsure, CapSure Lead, and CapSure Model Families of Leads, Thera-1 DR and Prodigy Families of IPGs and Service Kit-Pacemaker Repair, Connector Port Pin Plug and ECG CableMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P900060/S045
7/13/11
Carbomedics Prosthetic Heart Valve (CPHV)Sorin Group USA, Inc.
Arvada, CO
80004
Addition of a new molding supplier for the manufacturing of components used to package the finished device.
P900061/S104
7/7/11
Defibrillation Support Device and Associate Leads, Caps, Accessories and SleevesMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P900061/S105
7/21/11
Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, ACE Header, ACE, Lead End Pin Cap, Oval Patch Lead, Undefined and Defibrillation Support DeviceMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P920015/S079
7/7/11
Sprint, Sprint Quattro, Subcutaneous, Sub-Q Defibrillation,
Transvene SVC Leads and Accessories
Medtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P920015/S080
7/21/11
“Y” Adaptor/ Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, DF-1 Connector Port Pin Plug, Tunneling Tool and Sprint Quattro, Subcutaneous, Transvene CS/SVC, Transvene DF1 and Transvene SVC Families of LeadsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P930014/S049
7/8/11
AcrySof and AcrySof ReSTOR Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Optimized initiation processes and casting filtration for the device.
P930014/S050
7/21/11
AcrySof Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Change from a manual proof-reading process to an automated proof-reading system.
P930014/S051
7/28/11
AcrySof Posterior Chamber Intraocular LensAlcon Research Ltd. Fort Worth, TX
76134
Additional Laminar Air Flow hoods in the Alcon Ireland facility.
P930014/S052
7/21/11
ACRYSOF and ACRYSOF ReSTOR Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Change in the Fill/ Flush Extraction System for the ACRYSOF and ACRYSOF ReSTOR Intraocular lenses.
P930014/S053
7/26/11
AcrySof Posterior Chamber Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Removal of detergent from the cleaning process.
P930029/S031
7/7/11
RF Conductr MC, RF Contactr, RF Enhancr II, RF Marinr MC 7F,
RF Marinr SC 5F, RF Marinr Unipolar, RF Conductr MC
Ablation Catheters
Medtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P930039/S057
7/7/11
CapSure, SureFix, Vitatron Crystalline ActFix, Vitatron and Pirouet S+ LeadsMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P930039/S058
7/27/11
CapSure, Vitatron Crystalline ActFix LeadsMedtronic, Inc.
Mounds View, MN
55112
Addition of second supplier of silicone tubing.
P930039/S059
7/21/11
CapSure, SureFix, Vitatron Crystalline ActFix and Vitatron Pirouet S+ Families of LeadsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P940015/S021
7/7/11
SynVisc® and Synvisc-One®Genzyme Corporation
Cambridge, MA
02142
Replacement of a polyethylene cylindrical tank with a stainless steel rotating blender system.
P950020/S045
7/20/11
Coronary Flextome Cutting BalloonBoston Scientific Corporation
Maple Grove, MN
55311
Use of an alternate mixer.
P950024/S032
7/7/11
CapSure Epicardial Pacing LeadMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P950024/S033
7/21/11
CapSure Epicardial Pacing LeadMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P960009/S119
7/6/11
Activa Family of NeurostimulatorsMedtronic Neuromodulation Minneapolis, MN
55432
Updating the welding equipment software at a vendor.
P960009/S120
7/7/11
Activa Family of INS/Soletra INS/ Kinetra INSMedtronic Neuromodulation
Minneapolis, MN
55432
Update statistical process control software.
P960009/S121
7/29/11
Activa Family, Soletra, KinetraMedtronic Neuromodulation
Minneapolis, MN
55432
Procedure modification to meet the requirements of updated industry standards.
P970003/S128
7/11/11
VNS Therapy® System Pulse GeneratorsCyberonics, Inc.
Houston, TX
77058
Use of a new laser marker in the manufacturing process of the pulse generators.
P970003/S129
7/20/11
VNS Therapy® Pulse GeneratorsCyberonics, Inc.
Houston, TX
77058
Upgrade of the automated functional test system.
D970003/S130
7/1/11
Insigna, Nexus, and Altrua Family of PacemakersBoston Scientific Corporation
St. Paul, MN
55112
Change to eliminate a shear strength test and a reduction in an ionic contamination monitor test frequency.
D970003/S131
7/7/11
Pulsar/Pulsar Max, Insigna, Altrua Brady Pulse GeneratorsBoston Scientific Corporation
St. Paul, MN
55112
Update the document containing the temperature exposure process instruction.
P970004/S117
7/6/11
InterStim II NeurostimulatorMedtronic Neuromodulation Minneapolis, MN
55432
Updating the welding equipment software at a vendor.
P970004/S118
7/7/11
InterStim Family of INSMedtronic Neuromodulation Minneapolis, MN 55432Update statistical process control software.
P970004/S119
7/29/11
InterStimMedtronic Neuromodulation
Minneapolis, MN
55432
Procedure modification to meet the requirements of updated industry standards.
P970012/S086
7/7/11
Kappa 400 IPGMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P970012/S087
7/21/11
Kappa 400 Family of IPGsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P970051/S078
7/21/11
Nucleus 24 Cochlear Implant SystemCochlear Americas Centennial, CO
80111
Changes to: 1) the test systems (acoustic and wireless) to update test equipment and firmware;
2) additional tests for the digital sound processing memory; 3) modification to test
Limits; and 4) minor changes to the system user interface and test report format.
P970051/S080
7/22/11
Nucleus Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Modification to Clean Room 2.
P980006/S020
7/8/11
Bausch & Lomb PureVision (balafilcon A) Soft Contact LensesBausch & Lomb, Incorporated
Rochester, NY 14609
Add an additional raw material supplier.
P980016/S303
7/7/11
EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Secura, Virtuoso, Virtuoso II, Protecta DR, Protecta VR, Protecta XT DR, and Protecta XT VR Product FamiliesMedtronic, Inc.
Mounds View, MN
55112
Upgrade to the auto- welder equipment software.
P980016/S304
7/7/11
CapSure Lead and EnTrust, Intrinsic, Marquis, Maximo, Maximo
II, Protecta, Protecta XT, Secura, Virtuoso, and Virtuoso II ICDs
Medtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P980016/S306
7/15/11
Maximo II, Secura and Virtuoso II ICD Product FamiliesMedtronic, Inc.
Mounds View, MN
55112
Six changes to Gen2 Hybrid Tester:
1) a change to the test decibel limit of the EGM CMR;
2) a change to the Telemetry B VizSense;
3) a change to the R034 Stress;
4) a change to the JTAG Full Energy delivery pulse width; 5) a change to LV1 Continuity; and 6) a change to the Current Drain AVVD RF Idd.
P980016/S307
7/13/11
Maximo II, Protecta, Protecta XT, Secura, Virtuoso II ICDsMedtronic, Inc.
Mounds View, MN 55112
Manufacturing process and location change for the diode used in the high voltage charging transformer.
P980016/S308
7/21/11
CapSure Family of Leads and Entrust, Intrinsic, Marquis, Maximo, Protecta DR/VR, Protecta XT DR/VR, Maximo II, Secura, Virtuoso and Virtuoso II Families of ICDsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P980016/S309
7/29/11
Marquis VR ICDMedtronic, Inc.
Mounds View, MN
55112
Additional device models to be included in the update to sterile packaging sealing parameters.
P980035/S230
7/7/11
350 Series, EnRhythm, Sigma, and Advisa Product FamiliesMedtronic, Inc.
Mounds View, MN
55112
Upgrade to the auto- welder equipment software.
P980035/S231
7/7/11
Medtronic 350 Series, Adapta, Advisa, AT500, EnPulse,
EnRhythm, Relia, Sensia, Sigma and Versa IPGs
Medtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P980035/S232
7/21/11
350 Series, Adapta, EnRhythm, Relia, Sensia, Sigma, Advisa, AT500, EnPulse and Versa Families of IPGsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P980035/S233
7/28/11
Adapta, Relia, Sensia, Versa Families of IPGsMedtronic, Inc.
Mounds View, MN
55112
Five Changes to Gen2 Hybrid Tester final test solution: 1) update to the Force Measure_ngt2 Module; 2) update the Pulse Amplitude and Pulse Width Test, Pulse Amplitude 7500 mV and Amplitude 7500 mV Test Sequences; 3) widen the tolerance of the stability check criteria for the Pulse Amplitude and Pulse Width Test ;
4) update the configuration settings for the Pulse Amplitude 7500 mV and Unipolar Bipolar Switch Test and the Inter-Chamber Crosstalk Test; and 5) update the Electrically Erasable Programmable Read Only Memory (EEPROM) Cyclic Redundancy Check (CRC).
P980035/S234
7/29/11
Medtronic 350 Series IPGMedtronic, Inc.
Mounds View, MN
55112
Additional device models to be included in the update to sterile packaging sealing parameters.
P980049/S064
7/1/11
Paradym VR and DRELA Medical, Inc./ Sorin Group
Plymouth, MN
55441
Alternate oven used for reflow soldering.
P980050/S063
7/7/11
Transvene CS/SVC LeadMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P980050/S064
7/21/11
Transvene CS/SVC (w/polyurethane sheath) Family of LeadsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P990001/S089
7/7/11
Vitatron DA+ C-Series and Vitatron DA+ T Series Family of ProductsMedtronic, Inc.
Mounds View, MN
55112
Upgrade to the auto- welder equipment software.
P990001/S090
7/7/11
Vitatron DA+ C- Series and Vitatron DA+ T-Series IPGsMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P990001/S091
7/21/11
Vita, Vitatron DA+ C-Series and Vitatron DA+
T-Series Families of IPGs
Medtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P990020/S046
7/13/11
AneuRx AAAdvantage Stent GraftMedtronic Vascular Santa Rosa, CA
95403
Reduction in the number of in-process inspection steps in two manufacturing processes of the delivery systems.
P990034/S023
7/29/11
Side Catheter Accessory Port Kits, Including BulkMedtronic Neuromodulation
Minneapolis, MN
55432
Procedure modification to meet the requirements of updated industry standards.
P000029/S069
7/28/11
Deflux Injectable GelSchiff & Company
West Caldwell, NJ
07006
Relocation of the Quality Control Laboratory to a new location within
Q-Med AB ’s existing facility.
P000037/S023
7/20/11
On-X Prosthetic Heart ValveOn-X Technologies, Inc.
Austin, TX
78752
Validations for a mass finishing process.
P010012/S269
7/28/11
Easytrak 2 LeadBoston Scientific Corporation
St. Paul, MN
55112
Change to the laser weld equipment used to manufacture pacing leads.
P010014/S032
7/28/11
Oxford® Partial Knee SystemBiomet, Inc.
Warsaw, IN
46581
Introduction of new equipment for cleaning and passivation of the metallic components of the Oxford® Partial Knee System.
P010015/S128
7/7/11
Syncra and Consulta CRT-PMedtronic, Inc.
Mounds View, MN
55112
Upgrade to the auto- welder equipment software.
P010015/S130
7/7/11
Attain Leads, Consulta, InSync III and Syncra CRT-PsMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P010015/S131
7/21/11
Attain Family of Leads and Syncra, Consulta, and InSync III Families of CRT-PsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P010015/S133
7/29/11
Syncra CRT-P, Consulta CRT-P, InSync CRT-P, InSync III CRT-PMedtronic, Inc.
Mounds View, MN
55112
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging.
P010031/S257
7/7/11
Concerto, Concerto II Consulta, InSync II Marquis, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Maximo II Product Families; Protecta and Protecta XT CRT-D FamiliesMedtronic, Inc.
Mounds View, MN
55112
Upgrade to the auto- welder equipment software.
P010031/S258
7/7/11
Concerto, Concerto II, Consulta, InSync Marquis, InSync II
Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT ICDs and
CRT-Ds
Medtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P010031/S260
7/15/11
Concerto II, Consulta and Maximo II CRT-D Product FamiliesMedtronic, Inc.
Mounds View, MN
55112
Six changes to Gen2 Hybrid Tester: 1) a change to the test decibel limit of the EGM CMR; 2) a change to the Telemetry B VizSense; 3) a change to the R034 Stress; 4) a change to the JTAG Full Energy delivery pulse width; 5) a change to LV1 Continuity; and 6) a change to the Current Drain AVVD RF Idd.
P010031/S261
7/13/11
Concerto II, Consulta, Maximo II, Protecta, Protecta XT CRT-DsMedtronic, Inc.
Mounds View, MN 55112
Manufacturing process and location change for the diode used in the high voltage charging transformer.
P010031/S262
7/21/11
Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Marquis, InSync Maximo, Protecta, Protecta XT, InSync Sentry and Maximo II Families of
CRT-Ds
Medtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P010031/S263
7/29/11
Protecta CRT-D and XT CRT-DMedtronic, Inc.
Mounds View, MN
55112
Additional device models to be included in the update to sterile packaging sealing parameters.
P020009/S076
7/25/11
Express and Express 2 Coronary Stent SystemsBoston Scientific Corporation
Maple Grove, MN
55311
Removal of an IPA wash step.
P030005/S078
7/1/11
Contak Renewal TR CRT-PBoston Scientific Corporation
St. Paul, MN
55112
Change to eliminate a shear strength test and a reduction in an ionic contamination monitor test frequency.
P030009/S056
7/27/11
Integrity Coronary Stent SystemMedtronic Vascular, Inc.
Santa Rosa, CA
95403
Semi-Automation of one of the Integrity stent manufacturing work steps.
P030009/S057
7/27/11
Endeavor Zotarolimus-Eluting Coronary Stent SystemsMedtronic Vascular, Inc.
Santa Rosa, CA
95403
Change in receiving inspection location for a component.
P030017/S121
7/27/11
Precision® Spinal Cord Stimulator SystemBoston Scientific Neuromodulation
Valencia, CA
91355
Add in-house equipment for the cable ablation process.
P030036/S033
7/7/11
SelectSecure Lead and Sleeve KitMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P030036/S034
7/21/11
Anchoring Sleeve Kit and SelectSure Family of LeadsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P030052/S008
7/20/11
UroVysion Bladder Cancer Kit AssayAbbott Molecular, Inc.
Des Plaines, IL
60018
Implementation of an in-process validated test method for restriction Enzyme Digest Gel Electrophoresis (DNA Restriction Analysis), change in digest restriction enzymes used in the in-process test, implementation of an in-process validated test method for DNA Concentration Determination by UV/Vis Absorbance Spectrophotometry, and addition of an incoming screening test for Dextran Sulfate.
P040012/S040
7/7/11
Acculink Carotid Stent SystemAbbott Vascular, Inc.
Santa Clara, CA
05054
Use of an alternate Radial Force Tester.
P040016/S074
7/25/11
VeriFLEX (Liberté) Coronary Stent SystemsBoston Scientific Corporation
Maple Grove, MN
55311
Removal of an IPA wash step.
P040020/S031
7/8/11
AcrySof and AcrySof ReSTOR Intraocular LensesAlcon Research, Ltd. Fort Worth, TX 76134Optimized initiation processes and casting filtration for the device.
P040020/S032
7/21/11
AcrySof ReSTOR Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Change from a manual proof-reading process to an automated proof-reading system.
P040020/S033
7/21/11
ACRYSOF and ACRYSOF ReSTOR Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Change in the Fill/ Flush Extraction System for the ACRYSOF and ACRYSOF ReSTOR Intraocular lenses.
P040020/S034
7/26/11
AcrySof ReSTOR Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX
76134
Removal of detergent from the cleaning process.
P040033/S021
7/27/11
Birmingham Hip Resurfacing (BHR) SystemSmith & Nephew
Memphis, TN
38116
Use of a new degreasing system at a contract manufacturer.
P040045/S024
7/1/11
VISTAKON (senofilcon A) Contact Lenses, Clear and Visibly Tinted with UV BlockerJohnson & Johnson Vision Care, Inc. Jacksonville, FL 32256Implementation of an alternative test method for the raw material for VISTAKON.
P040047/S020
7/8/11
Coaptite Injectable ImplantMerz Aesthetics, Inc. Franksville, WI
53126
Addition of an inspection test and associated equipment, for the Coaptite Injectable Implant syringe component.
P050020/S036
7/6/11
FreeStyle Navigator Continuous Glucose Monitoring SystemAbbott Laboratories Alameda, CA
94502
Update to their First Article Inspection (FAI) procedure.
P050037/S030
7/8/11
Radiesse Injectable ImplantMerz Aesthetics, Inc. Franksville, WI
53126
Inclusion of bore gauge testing to incoming inspection of syringe barrels for the device.
P050044/S018
7/26/11
Vital Surgical HemostatOrthovita, Inc.
Malvern, PA
19355
Use of an automated washer as an alternative to manual cleaning of equipment and components used in the production of Vitagel Surgical Hemostat.
P050047/S017
7/21/11
Juvéderm Hyaluronate Gel ImplantsAllergan
Goleta, CA
93117
Change in the sterilization validation method for the Juvéderm Hyaluronate Gel Implants.
P050049/S007
7/1/11
Abbott AxSYM HBsAg and HBsAg ConfirmatoryAbbott Laboratories Abbott Park, IL
60064
Addition of an HBsAg positive plasma supplier and a change to quality control testing.
P050052/S033
7/8/11
Radiesse Injectable ImplantMerz Aesthetics, Inc. Franksville, WI
53126
Inclusion of bore gauge testing to incoming inspection of syringe barrels for the device.
P060008/S073
7/25/11
Taxus Liberté Paclitaxel-Eluting Coronary Stent SystemsBoston Scientific Corporation
Maple Grove, MN
55311
Removal of an IPA wash step.
P060027/S031
7/1/11
Paradym CRT-D 8750ELA Medical, Inc./ Sorin Group
Plymouth, MN
55441
Alternate oven used for reflow soldering.
P060039/S027
7/7/11
Attain Starfix LeadMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P060039/S028
7/21/11
Attain StarFix Family of leadsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P070007/S031
7/13/11
Talent Thoracic Stent GraftMedtronic Vascular Santa Rosa, CA
95403
Reduction in the number of in-process inspection steps in two manufacturing processes of the delivery systems.
P070008/S025
7/22/11
Corox OTW-L BP LeadsBiotronik, Inc.
Lake Oswego, OR
97035
Approval for an alternate sterilizer.
P070015/S074
7/1/11
XIENCE V Everolimus Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92591
Change to a manufacturing process of supplied acetone.
P070022/S021
7/26/11
Adiana Permanent Contraception SystemHologic, Inc.
Marlborough, MA
01725
Changes to the manufacturing and soldering process of a component of the device.
P070027/S030
7/13/11
Talent Abdominal Stent GraftMedtronic Vascular Santa Rosa, CA
95403
Reduction in the number of in-process inspection steps in two manufacturing processes of the delivery systems.
P080006/S030
7/7/11
Attain Ability, Attain Ability Plus and Attain Ability Straight LeadsMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P080006/S031
7/13/11
Attain Ability Plus LV LeadsMedtronic, Inc.
Mounds View, MN
55112
Transfer of incoming inspection activities for specific components to a different facility.
P080006/S032
7/21/11
Attain Ability, Attain Ability Plus and Attain Ability Straight Families of LeadsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P080025/S009
7/6/11
InterStim II NeurostimulatorMedtronic Neuromodulation Minneapolis, MN
55432
Updating the welding equipment software at a vendor.
P080025/S010
7/7/11
InterStim Family of INSMedtronic Neuromodulation Minneapolis, MN 55432Update statistical process control software.
P080025/S011
7/29/11
InterStim Family of Implantable Neurostimulators, Leads, Extensions and Accessory KitsMedtronic Neuromodulation
Minneapolis, MN
55432
Procedure modification to meet the requirements of updated industry standards.
P090013/S027
7/7/11
Revo MRI Product FamilyMedtronic, Inc.
Mounds View, MN
55112
Upgrade to the auto- welder equipment software.
P090013/S029
7/7/11
CapSure Fix Lead and Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P090013/S030
7/21/11
CapSure Fix Family of Leads and Revo MRI Family of IPGsMedtronic, Inc.
Mounds View, MN
55112
Updating the EO Residual Test procedure in response to a new standard.
P100023/S006
7/13/11
ION Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Elimination of two redundant inspection steps.
P100023/S007
7/25/11
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Removal of an IPA wash step.
P100023/S008
7/27/11
ION™ (TAXUS Element) Paclitaxel- Eluting Platinum Chromium Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Alternate inherent viscosity test method for testing of Aeson-blended resin and annealed gradient outer tubing component, and an up of associated specifications.
P100023/S010
7/27/11
ION (Taxus Element) Paclitaxel-Eluting Platinum Chromium Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Software upgrades to the stent inspection system.
P100029/S005
7/1/11
Trifecta ValveSt. Jude Medical, Inc.
St. Paul, MN
55117
Automated method for stent dimensional inspection.
P100029/S006
7/7/11
Trifecta ValveSt. Jude Medical, Inc.
St. Paul, MN
55117
Addition of an alternate vendor for stent tubing material.
P100031/S001
7/22/11
Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti- HBc on the MODULAR ANALYTICS E170 Immunoassay AnalyzerRoche Diagnostics
Indianapolis, IN
46250
 
Change within the manufacturing site to increase production capacity for a component of the streptavidin- coated microparticles used in both of these assays.
P100032/S001
7/22/11
Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti- HBc on the Elecsys 2010 Immunoassay AnalyzerRoche Diagnostics
Indianapolis, IN
46250
 
Change within the manufacturing site to increase production capacity for a component of the streptavidin- coated microparticles used in both of these assays.
P100040/S006
7/13/11
Valiant Thoracic Stent GraftMedtronic Vascular Santa Rosa, CA
95403
Reduction in the number of in-process inspection steps in two manufacturing processes of the delivery systems.

Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 76

Summary of PMA Originals Under Review
Total Under Review: 96
Total Active: 42
Total On Hold: 54
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 682
Total Active: 471
Total On Hold: 211
Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received
Originals: 6
Supplements: 60

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 76
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 219.8
FDA Time: 114.1 Days MFR Time: 105.7 Days