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 | E-LUMINEXX VASCULAR STENT |
Generic Name | STENT, ILIAC |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. TEMPE, AZ 85281 |
PMA Number | P080007 |
Supplement Number | S015 |
Date Received | 11/09/2012 |
Decision Date | 04/12/2013 |
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 A STERILIZATION SITE LOCATED AT STERIGENICS BELGIUM PETIT RECHAIN, S.A., IN VERVIERS, BELGIUM. |
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