PMA P000037
- Device
- On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (On-X AAP)
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S060
- Product code
- LWQ
- Decision date
- 2026-08-04
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- revisions to manufacturing and inspection procedures for the graft collar material
Current openFDA PMA Record#
- Device
- On-X Prosthetic Heart Valves and Ascending Aortic Prothesis (On-X AAP)
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S071
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2026-08-04
- Decision code
- OK30
- Date received
- 2026-07-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- revisions to manufacturing and inspection procedures for the graft collar material