PMA P900060S030

Device
CARBOMEDICS PROSTETIC HEART VALVE (CPHV)
Applicant
Corcym S.r.l.
PMA number
P900060
Supplement
S030
Product code
LWQ
Decision date
2005-04-08
Classification
Heart-valve, Mechanical
Generic name
HEART-VALVE, MECHANICAL
Approval order statement
APPROVAL FOR A CHANGE IN THE LOCK WIRE FABRICATION FOR THE CARBOMEDICS PROSTHETIC HEART VALVE.

Current openFDA PMA Record#

Device
CARBOMEDICS PROSTETIC HEART VALVE (CPHV)
Applicant
Corcym S.r.l.
PMA number
P900060
Supplement
S030
Product code
LWQ
Generic name
HEART-VALVE, MECHANICAL
Decision date
2005-04-08
Decision code
APPR
Date received
2005-01-27
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A CHANGE IN THE LOCK WIRE FABRICATION FOR THE CARBOMEDICS PROSTHETIC HEART VALVE.