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 | S001 |
Date Received | 10/11/2019 |
Decision Date | 10/30/2019 |
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 Change to the UV cure bonding step. |
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