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 | Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System |
Generic Name | STENT, CAROTID |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P060001 |
Supplement Number | S035 |
Date Received | 11/15/2022 |
Decision Date | 12/15/2022 |
Product Code |
NIM |
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 Addition of a new electropolishing station to the manufacturing process. |
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