|
Device | RX ACCULINK CAROTID STENT SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P040012 |
Supplement Number | S056 |
Date Received | 01/04/2016 |
Decision Date | 03/04/2016 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the following changes to the post-approval study for the device:request to modify the conditions of approval follow-up requirement from 3 to 2 years. |