MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL

FDA premarket approval P060038/S017 · decided 2014-04-18

Approval details

PMA number

P060038

Supplement

S017

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL

Generic name

heart-valve, non-allograft tissue

Applicant

Corcym Canada Corp

Date received

2013-07-01

Decision date

2014-04-18

Days to decision

291 days

Decision code

APPR

Product code

LWR

Advisory committee

Cardiovascular

Expedited review

No

Location

Burnaby

Statement

APPROVAL FOR MANUFACTURING PROCESS CHANGES TO THE MITROFLOW AORTIC PERICARDIAL HEART VALVE, MODEL LX, CONSISTING OF IMPLEMENTATION OF THE PHOSPHOLIPID REDUCTION TREATMENT MANUFACTURING PROCESS (AN ANTICALCIFICATION TREATMENT PROCESS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.