|
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 | S007 |
Date Received | 03/07/2013 |
Decision Date | 08/29/2013 |
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 a change to the primary/secondary packaging and labeling for the contegra pulmonary valved conduit (models 200 and 200s). |