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™ RX Carotid Stent System, tégé™ GPS™ Self-Expanding Peripheral Stent System |
Generic Name | STENT, CAROTID |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P060001 |
Supplement Number | S040 |
Date Received | 03/07/2024 |
Decision Date | 04/05/2024 |
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 a new sterilization cycle with reduced EO concentration using chamber 71 at the contract sterilizer |
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