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PMA P790007S047

Device
THE HANCOCK VALVED CONDUIT MODIFIED ORIFICE (MODEL 105)
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S047
Product code
LWR
Decision date
2016-04-28
Classification
Heart-valve, Non-allograft Tissue
Generic name
heart-valve, non-allograft tissue
Approval order statement
Approval for packaging and labeling changes for the Hancock Valved Conduit Modified Orifice (Model 105) and the Hancock Valved Conduit Low Porosity (Model 150).

Current openFDA PMA Record#

Device
THE HANCOCK VALVED CONDUIT MODIFIED ORIFICE (MODEL 105)
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S047
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2016-04-28
Decision code
APPR
Date received
2016-01-29
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for packaging and labeling changes for the Hancock Valved Conduit Modified Orifice (Model 105) and the Hancock Valved Conduit Low Porosity (Model 150).