PMA P160035S022
- Device
- EXCOR® Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S022
- Product code
- DSQ
- Decision date
- 2021-11-02
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Update to firmware parameters in the Ikus driving unit battery of the new CTM battery.
Current openFDA PMA Record#
- Device
- EXCOR® Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S022
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-11-02
- Decision code
- OK30
- Date received
- 2021-10-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to firmware parameters in the Ikus driving unit battery of the new CTM battery.