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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 | S016 |
Date Received | 03/14/2016 |
Decision Date | 07/20/2016 |
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 a change in supplier for the dc to dc converter printed circuit board used in the ikus driving unit. |