PMA P790007S046

Device
HANCOCK MODIFIED ORIFICE VALUED CONDUIT
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S046
Product code
LWR
Decision date
2015-11-04
Classification
Heart-valve, Non-allograft Tissue
Generic name
heart-valve, non-allograft tissue
Approval order statement
THE ADDITION OF THREE NEW PORCINE TISSUE SUPPLIERS.

Current openFDA PMA Record#

Device
HANCOCK MODIFIED ORIFICE VALUED CONDUIT
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S046
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2015-11-04
Decision code
OK30
Date received
2015-10-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
THE ADDITION OF THREE NEW PORCINE TISSUE SUPPLIERS.