|
Device | SUPERA PERIPHERAL STENT SYSTEM |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P120020 |
Supplement Number | S008 |
Date Received | 04/13/2015 |
Decision Date | 05/12/2015 |
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 MOVE THE ENDOTOXIN TESTING PRIOR TO STERILIZATION. |