PMA P900060S042

Device
CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES
Applicant
Corcym S.r.l.
PMA number
P900060
Supplement
S042
Product code
LWQ
Decision date
2011-06-30
Generic name
HEART-VALVE, MECHANICAL
Approval order statement
CHANGE OF A SUPPLIER FOR LOCK WIRE COMPONENTS.

Current openFDA PMA Record#

Device
CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES
Applicant
Corcym S.r.l.
PMA number
P900060
Supplement
S042
Product code
LWQ
Generic name
HEART-VALVE, MECHANICAL
Decision date
2011-06-30
Decision code
OK30
Date received
2011-06-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE OF A SUPPLIER FOR LOCK WIRE COMPONENTS.