PMA P790007S018

Device
HANCOCK MO VALVED CONDUITS, MODEL 150
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S018
Product code
LWR
Decision date
2007-05-10
Generic name
heart-valve, non-allograft tissue
Approval order statement
CHANGE TO THE SUPPLIER OF THE POLYPROPYLENE RESIN USED FOR THE INJECTION MOLDING OF THE FINAL CONTAINER LIDS.

Current openFDA PMA Record#

Device
HANCOCK MO VALVED CONDUITS, MODEL 150
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S018
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2007-05-10
Decision code
OK30
Date received
2007-04-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE SUPPLIER OF THE POLYPROPYLENE RESIN USED FOR THE INJECTION MOLDING OF THE FINAL CONTAINER LIDS.