PMA P900060S022

Device: CARBOMEDICS PROSTHETIC HEART VALVE
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S022
Product code: LWQ
Decision date: 2001-02-16
Classification: Heart-valve, Mechanical
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: INCREASING THE STERILIZATION LOAD SIZE FOR CPHV(TM) AND UTILIZE MIXED LOADS OF CPHV(TM) AND ANNULOPLASTY RINGS (ANNULOFLO(R), AND/OR ANNULOFLEX(TM), TO MAXIMUM OF 384 BARRIERS IN THE SAME CYCLE AT TH EAUSTIN AND CALGARY FACILITIES.

Current openFDA PMA Record#

Device: CARBOMEDICS PROSTHETIC HEART VALVE
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S022
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2001-02-16
Decision code: OK30
Date received: 2001-01-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: INCREASING THE STERILIZATION LOAD SIZE FOR CPHV(TM) AND UTILIZE MIXED LOADS OF CPHV(TM) AND ANNULOPLASTY RINGS (ANNULOFLO(R), AND/OR ANNULOFLEX(TM), TO MAXIMUM OF 384 BARRIERS IN THE SAME CYCLE AT TH EAUSTIN AND CALGARY FACILITIES.