PMA P000037S046
- Device
- ON-X PROSTHETIC HEART VALVE and On-X Ascending Aortic Prothesis
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S046
- Product code
- LWQ
- Decision date
- 2016-07-25
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Use of an additional Coordinate Measuring Machine for heart valve housing measurements.
Current openFDA PMA Record#
- Device
- ON-X PROSTHETIC HEART VALVE and On-X Ascending Aortic Prothesis
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S046
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2016-07-25
- Decision code
- OK30
- Date received
- 2016-07-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an additional Coordinate Measuring Machine for heart valve housing measurements.