PMA P900060S021

Device: CARBOMEDICS(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S021
Product code: LWQ
Decision date: 2000-09-05
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: CHANGE TO A LARGER CAPACITY CHAMBER USED TO STERILIZE THE SULZER CARBOMEDICS CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS. THIS LARGER CAPACITY CHAMBER IS LOCATED AT THE FACILITY IDENTIFIED AS SULZER VASCUTEK LOCATED IN SCOTLAND.

Current openFDA PMA Record#

Device: CARBOMEDICS(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S021
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2000-09-05
Decision code: OK30
Date received: 2000-08-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO A LARGER CAPACITY CHAMBER USED TO STERILIZE THE SULZER CARBOMEDICS CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS. THIS LARGER CAPACITY CHAMBER IS LOCATED AT THE FACILITY IDENTIFIED AS SULZER VASCUTEK LOCATED IN SCOTLAND.