PMA P790007S033

Device
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S033
Product code
LWR
Decision date
2012-12-19
Generic name
heart-valve, non-allograft tissue
Approval order statement
MODIFICATION OF THE DIMENSIONS OF AN EXISTING CLEAN ROOM.

Current openFDA PMA Record#

Device
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
Applicant
Medtronic Heart Valves
PMA number
P790007
Supplement
S033
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2012-12-19
Decision code
OK30
Date received
2012-11-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MODIFICATION OF THE DIMENSIONS OF AN EXISTING CLEAN ROOM.