|
Device | ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P040012 |
Supplement Number | S057 |
Date Received | 09/26/2016 |
Decision Date | 01/05/2017 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01445613
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of the CANOPY Post-Approval Study (PAS) results to the Instructions for Use (IFU). |