PMA P790007S049

Device
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S049
Product code
LWR
Decision date
2016-11-21
Classification
Heart-valve, Non-allograft Tissue
Generic name
heart-valve, non-allograft tissue
Approval order statement
Addition of three new porcine tissue suppliers.

Current openFDA PMA Record#

Device
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S049
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2016-11-21
Decision code
OK30
Date received
2016-10-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of three new porcine tissue suppliers.