|
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 | S018 |
Date Received | 09/28/2020 |
Decision Date | 10/27/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change the end of life and maintenance schedule of the manual air pump provided with each Ikus driving unit. |