PMA P000037S030
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S030
- Product code
- LWQ
- Decision date
- 2015-04-01
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR A LABELING CHANGE TO ALLOW AORTIC VALVE REPLACEMENT PATIENTS TO BE TREATED USING A LOWERED ANTICOAGULATION TARGET.
Current openFDA PMA Record#
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S030
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2015-04-01
- Decision code
- APPR
- Date received
- 2012-10-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A LABELING CHANGE TO ALLOW AORTIC VALVE REPLACEMENT PATIENTS TO BE TREATED USING A LOWERED ANTICOAGULATION TARGET.