PMA P790007S056

Device
Hancock Modified Orifice Valved Conduit
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S056
Product code
LWR
Decision date
2018-04-19
Classification
Heart-valve, Non-allograft Tissue
Generic name
heart-valve, non-allograft tissue
Approval order statement
Addition of a new porcine tissue supplier.

Current openFDA PMA Record#

Device
Hancock Modified Orifice Valved Conduit
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S056
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2018-04-19
Decision code
OK30
Date received
2018-04-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a new porcine tissue supplier.