PMA P090013S013
- Device
- REVO MRI SURESCAN PACING SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S013
- Product code
- LWP
- Decision date
- 2011-05-27
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR MODEL 2490G (VERSION 9V5) MEDTRONIC CARELINK MONITOR AND MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (REVO MRI SW018 XMLTU AND ENRHYTHM MRI V7.3 SW005 XMLTU).
Current openFDA PMA Record#
- Device
- REVO MRI SURESCAN PACING SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S013
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2011-05-27
- Decision code
- APPR
- Date received
- 2011-03-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODEL 2490G (VERSION 9V5) MEDTRONIC CARELINK MONITOR AND MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (REVO MRI SW018 XMLTU AND ENRHYTHM MRI V7.3 SW005 XMLTU).