|
Trade Name | EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE |
Classification Name | pediatric ventricular assist device |
Generic Name | pediatric ventricular assist device |
Regulation Number | 870.3545 |
Applicant |
Berlin Heart Inc. |
200 valleywood |
suite b100 |
the woodlands, TX 77380 |
|
HDE Number | H100004 |
Supplement Number | S019 |
Date Received | 07/15/2016 |
Decision Date | 02/27/2017 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for two new alternate suppliers of lubricant used in the manufacturing of the excor blood pumps. |