PMA P980035S249

Device
ADVISA & ENRHYTHM
Applicant
Medtronic, Inc.
PMA number
P980035
Supplement
S249
Product code
NVZ
Decision date
2011-12-06
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.

Current openFDA PMA Record#

Device
ADVISA & ENRHYTHM
Applicant
Medtronic, Inc.
PMA number
P980035
Supplement
S249
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2011-12-06
Decision code
APPR
Date received
2011-11-10
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490G MEDTRONIC CARELINK REMOTE HOME MONITOR, MODEL 2020A MEDTRONIC CARDIOSIGHT READER AND MODEL 2020B CARELINK EXPRESS MONITOR.