PMA P900060S029

Device: CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S029
Product code: LWQ
Decision date: 2004-07-02
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS TO THE STERILIZATION PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN A BIOLOGICAL INDICATOR.

Current openFDA PMA Record#

Device: CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S029
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2004-07-02
Decision code: OK30
Date received: 2004-06-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS TO THE STERILIZATION PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN A BIOLOGICAL INDICATOR.