|
Device | EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P110023 |
Supplement Number | S038 |
Date Received | 08/10/2023 |
Decision Date | 09/05/2023 |
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 Changes in the composition, suppliers and location for a cyanoacrylate adhesive used in the delivery catheter. |