PMA P790007S032

Device: HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150
Applicant: Medtronic Heart Valves
PMA number: P790007
Supplement: S032
Product code: LWR
Decision date: 2013-01-10
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: APPROVAL FOR THE GLUTARALDEHYDE STOCK SOLUTION THAT IS OBTAINED FROM DOWCHEMICAL FOR THE FIXATIVE, STORAGE, AND STERILIZATION SOLUTIONS TO BE CHANGED FROM A 25% STOCK SOLUTION TO A 50% STOCK SOLUTION.

Current openFDA PMA Record#

Device: HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150
Applicant: Medtronic Heart Valves
PMA number: P790007
Supplement: S032
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2013-01-10
Decision code: APPR
Date received: 2012-03-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE GLUTARALDEHYDE STOCK SOLUTION THAT IS OBTAINED FROM DOWCHEMICAL FOR THE FIXATIVE, STORAGE, AND STERILIZATION SOLUTIONS TO BE CHANGED FROM A 25% STOCK SOLUTION TO A 50% STOCK SOLUTION.