|
Trade Name | Graftmaster® RX Coronary Stent Graft System |
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 | S023 |
Date Received | 05/15/2023 |
Decision Date | 06/14/2023 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Alternative sourcing of raw materials for one of the adhesives. |