|
Device | EXCOR Pediatric Ventricular Assist Device |
Generic Name | Ventricular (assist) bypass |
Applicant | Berlin Heart Inc. 9391 Grogan's Mill Road, Suite A-6 The Woodlands, TX 77380 |
PMA Number | P160035 |
Supplement Number | S010 |
Date Received | 10/04/2019 |
Decision Date | 12/20/2019 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for optimization of the PU-A solution used in the production of the driving membranes. |