|
Device | COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P110040 |
Supplement Number | S005 |
Date Received | 03/04/2014 |
Decision Date | 04/03/2014 |
Withdrawal Date
|
05/23/2019 |
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 IMPLEMENTATION OF NEW COATING EQUIPMENT AND PROCESS CONTROLS. |