PMA P000037S067
- Device
- On-X Ascending Aortic Prosthesis
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S067
- Product code
- LWQ
- Decision date
- 2025-12-17
- Classification
- Cardiovascular
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- to increase the blue soiling acceptance criteria limit for the vascular prosthesis component of the On-X Ascending Aorta Prosthesis
Current openFDA PMA Record#
- Device
- On-X Ascending Aortic Prosthesis
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S067
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2025-12-17
- Decision code
- OK30
- Date received
- 2025-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to increase the blue soiling acceptance criteria limit for the vascular prosthesis component of the On-X Ascending Aorta Prosthesis