PMA P060038S030

Device: MITROFLOW AORTIC PERICARDIAL HEART VALVE
Applicant: Corcym Canada Corp
PMA number: P060038
Supplement: S030
Product code: LWR
Decision date: 2016-09-14
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: Upgrade to the Covered Stent Controlled Environment (CSCE) from a lower ISO cleanroom classification to a higher classification as well as the extension of covered stent manufacturing activities to two additional controlled environments.

Current openFDA PMA Record#

Device: MITROFLOW AORTIC PERICARDIAL HEART VALVE
Applicant: Corcym Canada Corp
PMA number: P060038
Supplement: S030
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2016-09-14
Decision code: OK30
Date received: 2016-08-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Upgrade to the Covered Stent Controlled Environment (CSCE) from a lower ISO cleanroom classification to a higher classification as well as the extension of covered stent manufacturing activities to two additional controlled environments.