PMA P000037S047
- Device
- ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S047
- Product code
- LWQ
- Decision date
- 2016-09-28
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Change to the secondary supplier for the valve holder and holder handle material.
Current openFDA PMA Record#
- Device
- ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S047
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2016-09-28
- Decision code
- OK30
- Date received
- 2016-08-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the secondary supplier for the valve holder and holder handle material.