PMA P160035S060
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S060
- Product code
- DSQ
- Decision date
- 2026-10-23
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- supplier and manufacturing process changes to the cannula silicone sheeting
Current openFDA PMA Record#
- Device
- EXCOR Pediatric Ventricular Assist Device
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S060
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-10-23
- Decision code
- OK30
- Date received
- 2026-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- supplier and manufacturing process changes to the cannula silicone sheeting