|
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 | S017 |
Date Received | 06/30/2006 |
Decision Date | 07/14/2006 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A TIGHTENING OF THE SAMPLING LEVEL FOR PARTIAL STENT DEPLOYMENT. |