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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 |
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HDE Number | H100004 |
Supplement Number | S017 |
Date Received | 05/03/2016 |
Decision Date | 07/14/2016 |
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 to (1) replace two sealing machines used for sealing the tyvek sterile packaging pouches and reels used for packaging the excor sterile components and (2) modify the seal strength specification for the sterile packaging pouches for the excor sterile components. |