PMA P000037S036
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S036
- Product code
- LWQ
- Decision date
- 2014-10-28
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR VERTICAL INTEGRATION OF A COMPONENT SUBSTRATE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S036
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2014-10-28
- Decision code
- APPR
- Date received
- 2014-06-03
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR VERTICAL INTEGRATION OF A COMPONENT SUBSTRATE MANUFACTURING PROCESS.