PMA P060038S026

Device: Crown PRT Aortic Pericardial Heart Valve with PR Treatment
Applicant: Corcym Canada Corp
PMA number: P060038
Supplement: S026
Product code: LWR
Decision date: 2016-01-13
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL DL, NAMELY THE ADDITION OF RADIOGRAPHIC MARKERS ON THE SEWING RING AND ADDITION OF VISIBLE MARKERS ON THE SEWING CUFF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CROWN PRT AORTIC PERICARDIAL HEART VALVE WITH PR TREATMENT AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.

Current openFDA PMA Record#

Device: Crown PRT Aortic Pericardial Heart Valve with PR Treatment
Applicant: Corcym Canada Corp
PMA number: P060038
Supplement: S026
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2016-01-13
Decision code: APPR
Date received: 2015-11-04
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL DL, NAMELY THE ADDITION OF RADIOGRAPHIC MARKERS ON THE SEWING RING AND ADDITION OF VISIBLE MARKERS ON THE SEWING CUFF. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CROWN PRT AORTIC PERICARDIAL HEART VALVE WITH PR TREATMENT AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.