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Device | EverFlex™ Self-Expanding Peripheral Stent System, 2 EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Sys |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P110023 |
Supplement Number | S045 |
Date Received | 04/15/2024 |
Decision Date | 05/02/2024 |
Product Code |
NIP |
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 removal of two post-electropolishing visual inspection scrap codes at the Medtronic Nathan Lane manufacturing facility in Plymouth, Minnesota |