PMA P900060S025

Device: CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROTHESIS
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S025
Product code: LWQ
Decision date: 2003-08-01
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM ONE TO FIVE YEARS FOR THE CARBOMEDICSCARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (AAP).

Current openFDA PMA Record#

Device: CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROTHESIS
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S025
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2003-08-01
Decision code: APPR
Date received: 2003-05-13
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM ONE TO FIVE YEARS FOR THE CARBOMEDICSCARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (AAP).