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 | Express SD Renal Monorail Premounted Stent System |
Generic Name | STENT, RENAL |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P060006 |
Supplement Number | S105 |
Date Received | 12/07/2022 |
Decision Date | 03/02/2023 |
Product Code |
NIN |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to approve an alternate supplier of an equivalent resin used as the middle layer in the tri-layer inner component of your stents delivery system. |
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