|
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 | S018 |
Date Received | 06/13/2018 |
Decision Date | 07/10/2018 |
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 Change the product bioburden sampling plan for coronary stent systems. |