PMA P000037S019
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S019
- Product code
- LWQ
- Decision date
- 2010-09-23
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN AUSTIN, TEXAS.
Current openFDA PMA Record#
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S019
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2010-09-23
- Decision code
- APPR
- Date received
- 2010-02-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN AUSTIN, TEXAS.