PMA P000037S052
- Device
- On-X Prosthetic Heart Valve, Model Onxa
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S052
- Product code
- LWQ
- Decision date
- 2018-10-18
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for the addition of an inspection to verify suture orientation marks.
Current openFDA PMA Record#
- Device
- On-X Prosthetic Heart Valve, Model Onxa
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S052
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2018-10-18
- Decision code
- APPR
- Date received
- 2018-09-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of an inspection to verify suture orientation marks.