PMA P160035S020
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S020
- Product code
- DSQ
- Decision date
- 2021-10-14
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Implementation of mobile test unit version 2 (MTU 2) with Hardware Extension for the pairing of batteries for the Ikus driving unit.
Current openFDA PMA Record#
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S020
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-10-14
- Decision code
- OK30
- Date received
- 2021-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of mobile test unit version 2 (MTU 2) with Hardware Extension for the pairing of batteries for the Ikus driving unit.