Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | OMNILINK ELITE VACULAR SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | ABBOTT VASCULAR-CARDIAC THERAPIES 3200 LAKESIDE DR. SANTA CLARA, CA 95054-2807 |
PMA Number | P110043 |
Supplement Number | S006 |
Date Received | 04/14/2014 |
Decision Date | 05/13/2014 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00844532
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Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF RAW MATERIALS AND SUPPLY ITEMS AT THE CLONMEL, IRELAND FACILITY AND CONTRACT LABORATORIES. |
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