- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S015
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-09-03
- Decision code
- OK30
- Date received
- 2020-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a new version of Mobile Test Unit (MTU) for testing the Ikus driving unit used with the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD)