FDA.reportPublic FDA data

PMA P000037S059

Device
On X Prosthetic Heart Valve Ascending Aortic Prothesis
Applicant
On-X Life Technologies, Inc.
PMA number
P000037
Supplement
S059
Product code
LWQ
Decision date
2022-03-24
Generic name
HEART-VALVE, MECHANICAL
Approval order statement
Implementation of a new Controlled Environment Area (CEA) to perform On-X Heart Valve (HV) and Ascending Aortic Prosthesis (AAP) manufacturing steps from subassembly through sterilization and final packaging.

Current openFDA PMA Record#

Device
On X Prosthetic Heart Valve Ascending Aortic Prothesis
Applicant
On-X Life Technologies, Inc.
PMA number
P000037
Supplement
S059
Product code
LWQ
Generic name
HEART-VALVE, MECHANICAL
Decision date
2022-03-24
Decision code
OK30
Date received
2022-03-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of a new Controlled Environment Area (CEA) to perform On-X Heart Valve (HV) and Ascending Aortic Prosthesis (AAP) manufacturing steps from subassembly through sterilization and final packaging.