PMA P090013S061

Device
REVO MRI
Applicant
Medtronic, Inc.
PMA number
P090013
Supplement
S061
Product code
LWP
Decision date
2012-04-25
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.

Current openFDA PMA Record#

Device
REVO MRI
Applicant
Medtronic, Inc.
PMA number
P090013
Supplement
S061
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2012-04-25
Decision code
APPR
Date received
2012-04-04
Supplement type
Real-Time Process
Approval order statement
APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.