PMA P900060S034

Device: PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S034
Product code: LWQ
Decision date: 2005-11-30
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: APPROVAL TO SUBSTITUTE AN OUTSIDE VENDOR FOR SPECIFIC METAL COMPONENTS OF THE PROSTHETIC HEART VALVES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES CARBOMEDICS PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (AAP).

Current openFDA PMA Record#

Device: PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S034
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2005-11-30
Decision code: APPR
Date received: 2005-09-06
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO SUBSTITUTE AN OUTSIDE VENDOR FOR SPECIFIC METAL COMPONENTS OF THE PROSTHETIC HEART VALVES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES CARBOMEDICS PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (AAP).