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 | EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE |
Applicant |
Berlin Heart Inc. |
200 valleywood |
suite b100 |
the woodlands, TX 77380 |
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HDE Number | H100004 |
Supplement Number | S003 |
Date Received | 01/17/2012 |
Decision Date | 07/27/2012 |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol - osb |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the post-approval study protocol. |
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