|
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 | S009 |
Date Received | 03/18/2014 |
Decision Date | 05/29/2014 |
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 the addition of a shielding box around the nurse call connector. |