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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 |
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HDE Number | H100004 |
Supplement Number | S013 |
Date Received | 09/11/2015 |
Decision Date | 11/17/2015 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the device labeling. The device, as modified, will be marketed under the trade name berlin heart excor pediatric ventricularassist device and is indicated for the following:excor pediatric ventricular assist device (referred to as excor) is intended to providemechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who arecandidates for cardiac transplant and require circulatory support may be treated using the excor. |