PMA P000037S050
- Device
- ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S050
- Product code
- LWQ
- Decision date
- 2017-12-05
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for an additional manufacturing lathe and a new coolant for the leaflet substrate grinding process.
Current openFDA PMA Record#
- Device
- ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S050
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2017-12-05
- Decision code
- APPR
- Date received
- 2017-01-25
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional manufacturing lathe and a new coolant for the leaflet substrate grinding process.