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 FLAIR ENDOVASCULAR STENT GRAFT |
Generic Name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
Applicant | BARD PERIPHERAL VASCULAR 1625 W. THIRD ST TEMPE, AZ 85281 |
PMA Number | P060002 |
Supplement Number | S015 |
Date Received | 08/10/2010 |
Decision Date | 09/08/2010 |
Withdrawal Date
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09/12/2022 |
Product Code |
PFV |
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 UPGRADE TO THE MAINTENANCE MANAGEMENT SOFTWARE PROGRAM USED TO TRACK AND SCHEDULE PREVENTATIVE MAINTENANCE TALK, EQUIPMENT, AND SUPPLIES. |
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