PMA P160035S056
- Device
- EXCOR Pediatric VAD
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S056
- Product code
- DSQ
- Decision date
- 2026-10-14
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the addition of a new polyol material supplier.
Current openFDA PMA Record#
- Device
- EXCOR Pediatric VAD
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S056
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-10-14
- Decision code
- APPR
- Date received
- 2025-11-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of a new polyol material supplier.