PMA P160035S049
- Device
- EXCOR Cannula Clip
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S049
- Product code
- DSQ
- Decision date
- 2025-09-12
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the EXCOR Cannula Clip
Current openFDA PMA Record#
- Device
- EXCOR Cannula Clip
- Applicant
- Berlin Heart, Inc.
- PMA number
- P160035
- Supplement
- S049
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2025-09-12
- Decision code
- APPR
- Date received
- 2025-03-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the EXCOR Cannula Clip