- Device
- ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, ON-X AORTIC PROSTHETIC HEART VALVE WITH A
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S048
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2017-02-07
- Decision code
- APPR
- Date received
- 2016-12-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval for multiple changes, including clinical changes to the current protocol for the post-approval study (PAS) protocol.