PMA P090013S017

Device
REVO MRI IPG
Applicant
Medtronic, Inc.
PMA number
P090013
Supplement
S017
Product code
LWP
Decision date
2011-05-19
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
PROCESS STANDARDIZATION FOR SELECTED CLEANING OPERATIONS

Current openFDA PMA Record#

Device
REVO MRI IPG
Applicant
Medtronic, Inc.
PMA number
P090013
Supplement
S017
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2011-05-19
Decision code
OK30
Date received
2011-04-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
PROCESS STANDARDIZATION FOR SELECTED CLEANING OPERATIONS