Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
|
Trade Name | JOSONICS GRAFTMASTER |
Classification Name | stent, coronary |
Generic Name | stent, coronary |
Applicant |
ABBOTT VASCULAR DEVICES |
26531 ynez road |
temecula, CA 92591 |
|
HDE Number | H000001 |
Supplement Number | S005 |
Date Received | 04/27/2004 |
Decision Date | 05/19/2004 |
Product Code | |
Docket Number | 01M-0062 |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for approval for a new assembly and packaging site, abbott vascular instruments deutschland gmbh, located at rudolph diesel stra~e 29, rangendingen, germany, and a new sterilization site, sterigenics, located at dreiceistrasse 7, mdhirdelden, germany. |
|
|