PMA P060038S002

Device: MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX
Applicant: Corcym Canada Corp
PMA number: P060038
Supplement: S002
Product code: LWR
Decision date: 2009-02-27
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: APPROVAL FOR MANUFACTURING PROCESS IMPROVEMENTS TO THE AORTIC PERICARDIAL HEART VALVE MODEL 12. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDE THE TRADE NAME MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.

Current openFDA PMA Record#

Device: MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX
Applicant: Corcym Canada Corp
PMA number: P060038
Supplement: S002
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2009-02-27
Decision code: APPR
Date received: 2008-12-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MANUFACTURING PROCESS IMPROVEMENTS TO THE AORTIC PERICARDIAL HEART VALVE MODEL 12. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDE THE TRADE NAME MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.