|
Device | RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P040012 |
Supplement Number | S015 |
Date Received | 03/01/2006 |
Decision Date | 06/26/2006 |
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 THE LOT HISTORY BILL OF MATERIALS TO REMOVE SPECIFIED QUALITY AUDITS THAT ARE NOT NECESSARY OR VALUE ADDED. |