PMA P160035S028
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S028
- Product code
- DSQ
- Decision date
- 2022-08-12
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Manufacturing change to the printed circuit board used in the Berlin Heart EXCOR IKUS Driver.
Current openFDA PMA Record#
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S028
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2022-08-12
- Decision code
- OK30
- Date received
- 2022-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change to the printed circuit board used in the Berlin Heart EXCOR IKUS Driver.