PMA P000037S064
- Device
- On-X Prosthetic Heart Valves; On-X Ascending Aortic Prothesis
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S064
- Product code
- LWQ
- Decision date
- 2025-10-22
- Classification
- Cardiovascular
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- an alternate paper for use in the Controlled Environment Areas (CEAs)
Current openFDA PMA Record#
- Device
- On-X Prosthetic Heart Valves; On-X Ascending Aortic Prothesis
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S064
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2025-10-22
- Decision code
- OK30
- Date received
- 2025-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate paper for use in the Controlled Environment Areas (CEAs)