|
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 | S017 |
Date Received | 01/26/2018 |
Decision Date | 02/21/2018 |
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 To change the time point when pyrogen testing for ethylene oxide (eo) sterilized products is conducted for products manufactured at its facility located in clonmel, ireland. |