PMA P000037S051
- Device
- On-X Ascending Aortic Prosthesis
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S051
- Product code
- LWQ
- Decision date
- 2017-12-14
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for an additional ethylene oxide sterilization site located at 1300 East Anderson Lane, Building B, Austin, Texas.
Current openFDA PMA Record#
- Device
- On-X Ascending Aortic Prosthesis
- Applicant
- On-X Life Technologies, Inc.
- PMA number
- P000037
- Supplement
- S051
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2017-12-14
- Decision code
- APPR
- Date received
- 2017-07-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional ethylene oxide sterilization site located at 1300 East Anderson Lane, Building B, Austin, Texas.