PMA P000037S053
- Device
- On-X Prosthetic Heart Valve
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S053
- Product code
- LWQ
- Decision date
- 2019-02-26
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Implementation of new tooling and modified CNC software used to machine On-X device housing substrates.
Current openFDA PMA Record#
- Device
- On-X Prosthetic Heart Valve
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S053
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2019-02-26
- Decision code
- OK30
- Date received
- 2018-12-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of new tooling and modified CNC software used to machine On-X device housing substrates.