|
Device | EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P110023 |
Supplement Number | S039 |
Date Received | 08/23/2023 |
Decision Date | 09/18/2023 |
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 Alternative to batch testing for bacterial endotoxin testing. |