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 | BARD 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 | S008 |
Date Received | 10/21/2011 |
Decision Date | 10/31/2011 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement INTRODUCTION OF AN AUTOMATED LABELING INSPECTION SYSTEM AND INTRODUCTION OF A NEW BARCODE SCAN SYSTEM. |
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