PMA P090013S055

Device
REVO MRI
Applicant
Medtronic, Inc.
PMA number
P090013
Supplement
S055
Product code
LWP
Decision date
2012-03-23
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.

Current openFDA PMA Record#

Device
REVO MRI
Applicant
Medtronic, Inc.
PMA number
P090013
Supplement
S055
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2012-03-23
Decision code
OK30
Date received
2012-02-29
Supplement type
30-Day Notice
Approval order statement
UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES.