PMA P910023S257

Device
CADENCE/CURRENT/FORTIFY FAMILIES OF ICDS
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S257
Product code
NVZ
Decision date
2011-06-21
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
APPROVAL FOR SOFTWARE MODEL MN5000 V.5.0 FOR USE ON THE MERLIN.NET SYSTEM AND MODEL EX2000 V.5.0 FOR USE ON MERLIN@ HOME DEVICES.

Current openFDA PMA Record#

Device
CADENCE/CURRENT/FORTIFY FAMILIES OF ICDS
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S257
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2011-06-21
Decision code
APPR
Date received
2011-03-14
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR SOFTWARE MODEL MN5000 V.5.0 FOR USE ON THE MERLIN.NET SYSTEM AND MODEL EX2000 V.5.0 FOR USE ON MERLIN@ HOME DEVICES.