PMA P000037S057
- Device
- On-X Prosthetic Heart Valve and On-X Ascending Aortic Prosthesis devices
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S057
- Product code
- LWQ
- Decision date
- 2021-03-04
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for changes to the polyester fiber in the suture component.
Current openFDA PMA Record#
- Device
- On-X Prosthetic Heart Valve and On-X Ascending Aortic Prosthesis devices
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S057
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2021-03-04
- Decision code
- APPR
- Date received
- 2020-12-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the polyester fiber in the suture component.