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 | JOMED JOSTENT GRAFT MASTER |
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 | S003 |
Date Received | 09/25/2001 |
Decision Date | 03/18/2003 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the over-the-wire delivery system, the 11, 14, 18, and 29 mm length jostent graft master for the jostent coronary stent graft; the addition of a new manufacturing facility, jomed, inc. , 15330 avenue of science, suite 200, san diego, california; the addition of a new contractsterilizer, griffith micro science/iba, 4900 south gifford avenue, losangeles, california, and removal of the formal on-site training requirement. |
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