|
Device | MULTI-LINK VISION CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR P.O. BOX 9018 TEMECULA, CA 92589-9018 |
PMA Number | P020047 |
Supplement Number | S006 |
Date Received | 06/12/2006 |
Decision Date | 07/13/2006 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS FOR THE IFUS TO INCLUDE ADDITIONAL INFORMATION REGARDING THE MATERIAL COMPONENTS OF THE STENTS. |