PMA P000037S060
- Device
- On- X Prosthetic Heart Valve, Ascending Aortic Prothesis
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S060
- Product code
- LWQ
- Decision date
- 2022-08-01
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Alternate defoaming agent used in the manufacturing process.
Current openFDA PMA Record#
- Device
- On- X Prosthetic Heart Valve, Ascending Aortic Prothesis
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S060
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2022-08-01
- Decision code
- OK30
- Date received
- 2022-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate defoaming agent used in the manufacturing process.