|
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 | S014 |
Date Received | 09/22/2015 |
Decision Date | 10/14/2015 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Manufacturing change to a cleaning solution. |