PMA P000037S045
- Device
- ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S045
- Product code
- LWQ
- Decision date
- 2016-05-31
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- the addition of a new piece of test equipment used in the manufacture of heart valve subassemblies
Current openFDA PMA Record#
- Device
- ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S045
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2016-05-31
- Decision code
- OK30
- Date received
- 2016-04-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a new piece of test equipment used in the manufacture of heart valve subassemblies