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 VASCULAR BALLOON-EXPANDABLE STENT SYTEM |
Generic Name | STENT, ILIAC |
Applicant | ABBOTT VASCULAR-CARDIAC THERAPIES 3200 LAKESIDE DR. SANTA CLARA, CA 95054-2807 |
PMA Number | P110043 |
Supplement Number | S003 |
Date Received | 10/01/2012 |
Decision Date | 11/16/2012 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN E-BEAM STERILIZATION SITE LOCATED AT SYNERGY HEALTH IRELAND IN OFFALY, IRELAND. |
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