|
Device | MULTI-LINK 8 AND MULTI-LINK 8 LL CORONARY STENT SYSTEM (CSS) |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR P.O. BOX 9018 TEMECULA, CA 92589-9018 |
PMA Number | P020047 |
Supplement Number | S046 |
Date Received | 02/22/2012 |
Decision Date | 08/20/2012 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A STERILIZATION SITE LOCATED IN TIPPERARY. IRELAND. |