|
Device | RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS |
Generic Name | STENT, CAROTID |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P040012 |
Supplement Number | S009 |
Date Received | 02/28/2006 |
Decision Date | 07/18/2006 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION TO A MANUFACTURING PROCESS TO IMPROVE WICKING OF GLUE BETWEEN THE HYPOTUBE AND THE INNER MEMBER AND A MODIFICATION TO THE LOT HISTORY RECORD BILL OF MATERIALS TO ADD A NEW BLOCK FOR DOCUMENTING THE NEW PROCESS. |