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 | Venovo Venous Stent System |
Generic Name | Stent, iliac vein |
Applicant | Bard Peripheral Vascular, Inc. 1625 West Third Street Tempe, AZ 85281 |
PMA Number | P180037 |
Supplement Number | S009 |
Date Received | 03/25/2022 |
Decision Date | 04/22/2022 |
Product Code |
QAN |
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 Delivery system manufacturing process and inspection changes for the 10 French device size. |
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