|
Trade Name | EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE |
Classification Name | ventricular (assist) bypass |
Generic Name | ventricular (assist) bypass |
Applicant |
Berlin Heart Inc. |
200 valleywood |
suite b100 |
the woodlands, TX 77380 |
|
HDE Number | H100004 |
Supplement Number | S006 |
Date Received | 08/24/2012 |
Decision Date | 11/26/2012 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | request for adn |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval that fda modify the annual distribution number (adn) for your humanitarian use device (hud) based on additional information regarding the adn. The hde supplement is approved with a new adn of 16,988. |