PMA P790007S037

Device
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S037
Product code
LWR
Decision date
2013-07-31
Classification
Heart-valve, Non-allograft Tissue
Generic name
heart-valve, non-allograft tissue
Approval order statement
APPROVAL TO USE TWO NEW AUTOCLAVES.

Current openFDA PMA Record#

Device
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S037
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2013-07-31
Decision code
APPR
Date received
2013-04-01
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL TO USE TWO NEW AUTOCLAVES.