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 | JOSTENT 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 | S008 |
Date Received | 10/09/2012 |
Decision Date | 04/03/2013 |
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 a change in delivery system, manufacturing site and revisions to the instructions for use (ifu). |
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