|
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 | S015 |
Date Received | 09/28/2017 |
Decision Date | 01/25/2018 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement To change the ethylene oxide (eo) sterilization release process for the affected products from using the traditional method of biological indicator testing to a parametric release process. |