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 | ABIOCOR |
Classification Name | artificial heart |
Generic Name | artificial heart |
Applicant |
ABIOMED, INC. |
22 cherry hill dr. |
danvers, MA 01923 |
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HDE Number | H040006 |
Supplement Number | S002 |
Date Received | 03/02/2007 |
Decision Date | 01/17/2008 |
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 specific hardware and software modifications to the abiocor@d device. These hardware and software modifications were specifically described inthe executive summary and in the abiocor@ modifications table. |
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