PMA P000037S029
- Device
- ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP)
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S029
- Product code
- LWQ
- Decision date
- 2012-09-19
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- MODIFICATION TO THE LIMULUS AMEBOCYTE LYSATE (LAL) TEST METHOD AND PROCEDURE.
Current openFDA PMA Record#
- Device
- ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP)
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S029
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2012-09-19
- Decision code
- OK30
- Date received
- 2012-08-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION TO THE LIMULUS AMEBOCYTE LYSATE (LAL) TEST METHOD AND PROCEDURE.