PMA P000037S054
- Device
- On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S054
- Product code
- LWQ
- Decision date
- 2019-08-15
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for the revised protocol for the Newly Enrolled On-X Post-Approval Study.
Current openFDA PMA Record#
- Device
- On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S054
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2019-08-15
- Decision code
- APPR
- Date received
- 2019-06-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the revised protocol for the Newly Enrolled On-X Post-Approval Study.