PMA P000037S033
- Device
- ON-X PROSTHETICHEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S033
- Product code
- LWQ
- Decision date
- 2013-11-14
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR SEVERAL CHANGES TO YOUR ROUTINE STERILIZATION PROCESS.
Current openFDA PMA Record#
- Device
- ON-X PROSTHETICHEART VALVE
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S033
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2013-11-14
- Decision code
- APPR
- Date received
- 2013-06-07
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR SEVERAL CHANGES TO YOUR ROUTINE STERILIZATION PROCESS.