PMA P000037S031
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S031
- Product code
- LWQ
- Decision date
- 2012-12-01
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- MOVE THE MACHINING PROCESS FOR SPECIFIED SIZES OF VALVE HOUSING SUBSTRATES IN-HOUSE.
Current openFDA PMA Record#
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S031
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2012-12-01
- Decision code
- OK30
- Date received
- 2012-11-14
- Supplement type
- 30-Day Notice
- Approval order statement
- MOVE THE MACHINING PROCESS FOR SPECIFIED SIZES OF VALVE HOUSING SUBSTRATES IN-HOUSE.