|
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 | S008 |
Date Received | 09/24/2015 |
Decision Date | 10/20/2015 |
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 CHANGES TO THE MANUFACTURING EQUIPMENT USED IN ASSEMBLY OF THE COMPLETE SE VASCULAR STENT SYSTEM. |