PMA P000037S016
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S016
- Product code
- LWQ
- Decision date
- 2009-10-16
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL TO MOVE A MANUFACTURING OPERATION FROM AN OUTSIDE VENDOR TO IN-HOUSE.
Current openFDA PMA Record#
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S016
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2009-10-16
- Decision code
- APPR
- Date received
- 2009-07-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO MOVE A MANUFACTURING OPERATION FROM AN OUTSIDE VENDOR TO IN-HOUSE.