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 | LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS) |
Applicant |
Abbott |
6035 stoneridge drive |
pleasanton, CA 94588 |
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HDE Number | H070004 |
Supplement Number | S001 |
Date Received | 10/24/2008 |
Decision Date | 05/22/2009 |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the post-approval study protocol. |
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