PMA P790007S035

Device
HANCOCK LOW POROSITY AND MOFIFIED ORIFICE VALVED CONDUIT
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S035
Product code
LWR
Decision date
2013-03-13
Generic name
heart-valve, non-allograft tissue
Approval order statement
ADDITION OF A NEW PORCINE HEART VALVE TISSUE SUPPLIER.

Current openFDA PMA Record#

Device
HANCOCK LOW POROSITY AND MOFIFIED ORIFICE VALVED CONDUIT
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S035
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2013-03-13
Decision code
OK30
Date received
2013-02-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW PORCINE HEART VALVE TISSUE SUPPLIER.