PMA P900060S026

Device: CARBOMEDICS PROSTHETIC HEART VALVE {CPHV}
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S026
Product code: LWQ
Decision date: 2003-07-25
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS OF THE PAPER USED IN THE MANUFACTURE OF THE VENT COVERS INCLUDED IN THE PACKAGING OF THE CARBOMEDICS PROSTHETIC HEART VALVE (CPHV).

Current openFDA PMA Record#

Device: CARBOMEDICS PROSTHETIC HEART VALVE {CPHV}
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S026
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2003-07-25
Decision code: OK30
Date received: 2003-06-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS OF THE PAPER USED IN THE MANUFACTURE OF THE VENT COVERS INCLUDED IN THE PACKAGING OF THE CARBOMEDICS PROSTHETIC HEART VALVE (CPHV).