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. |
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Trade Name | JOSONICS GRAFTMASTER |
Classification Name | stent, coronary |
Generic Name | stent, coronary |
Applicant |
ABBOTT VASCULAR DEVICES |
26531 ynez road |
temecula, CA 92591 |
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HDE Number | H000001 |
Supplement Number | S006 |
Date Received | 05/09/2006 |
Decision Date | 03/07/2007 |
Product Code | |
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 a sterilization site located at sterigenics germany gmbh, rheigaustrasse 190-196, gebaeude g525, wiesbaden, germany. |
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