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. |
|
Trade Name | EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE |
Applicant |
Berlin Heart Inc. |
200 valleywood |
suite b100 |
the woodlands, TX 77380 |
|
HDE Number | H100004 |
Supplement Number | S005 |
Date Received | 04/06/2012 |
Decision Date | 05/17/2012 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
|
|