|
Trade Name | GRAFT MASTER RX CORONARY STENT GRAFT SYSTM |
Classification Name | coronary covered stent |
Generic Name | coronary covered stent |
Applicant |
ABBOTT VASCULAR DEVICES |
26531 ynez road |
temecula, CA 92591 |
|
HDE Number | H000001 |
Supplement Number | S014 |
Date Received | 12/06/2016 |
Decision Date | 02/17/2017 |
Product Code | |
Advisory Committee |
Cardiovascular |
Clinical Trials |
NCT01435031
|
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to the device labeling. |