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 and VICI RDS Stent System |
Generic Name | Stent, iliac vein |
Applicant | Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P180013 |
Supplement Number | S006 |
Date Received | 07/22/2020 |
Decision Date | 02/11/2021 |
Product Code |
QAN |
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 the transfer of the finished device manufacturing site from Fremont, California to Galway, Ireland, the addition of new sterilization sites and cycles, and a change in legal manufacturer from Veniti, Inc. to Boston Scientific Corporation. |
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