PMA P090013S102

Device
REVO MRI IPG
Applicant
Medtronic, Inc.
PMA number
P090013
Supplement
S102
Product code
LWP
Decision date
2013-06-26
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
ADDITION OF A NEW PRESS FOR THE PIN INSERTION OPERATION.

Current openFDA PMA Record#

Device
REVO MRI IPG
Applicant
Medtronic, Inc.
PMA number
P090013
Supplement
S102
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2013-06-26
Decision code
OK30
Date received
2013-05-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW PRESS FOR THE PIN INSERTION OPERATION.