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 | VICI VENOUS STENT System |
Generic Name | Stent, iliac vein |
Applicant | Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P180013 |
Supplement Number | S004 |
Date Received | 03/10/2020 |
Decision Date | 09/03/2020 |
Product Code |
QAN |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the second stent delivery system – the VICI RDS Venous Stent System. |
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