PMA P000037S017
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S017
- Product code
- LWQ
- Decision date
- 2010-01-14
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL TO CHANGE THE MATERIAL SPECIFICATIONS FOR THE SEWING CUFF PTFE FABRIC USED IN THE ASSEMBLY OF THE ON-X VALVE.
Current openFDA PMA Record#
- Device
- ON-X PROSTHETIC HEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S017
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2010-01-14
- Decision code
- APPR
- Date received
- 2009-11-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO CHANGE THE MATERIAL SPECIFICATIONS FOR THE SEWING CUFF PTFE FABRIC USED IN THE ASSEMBLY OF THE ON-X VALVE.