PMA P900060S033

Device: CARBOMEDICS PROSTHETIC HEART VALVE
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S033
Product code: LWQ
Decision date: 2006-07-21
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT THE SORIN BIOMEDICA CARDIO, S.R.L. FACILITY IN SALUGGIA, ITALY TO MANUFACTURE PYROLYTIC CARBON COMPONENTS FOR THE CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC PROSTHESIS AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS DEVICES.

Current openFDA PMA Record#

Device: CARBOMEDICS PROSTHETIC HEART VALVE
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S033
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2006-07-21
Decision code: APPR
Date received: 2005-05-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT THE SORIN BIOMEDICA CARDIO, S.R.L. FACILITY IN SALUGGIA, ITALY TO MANUFACTURE PYROLYTIC CARBON COMPONENTS FOR THE CARBOMEDICS PROSTHETIC HEART VALVE, CARBO-SEAL ASCENDING AORTIC PROSTHESIS AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS DEVICES.