PMA P090013S220
- Device
- REVO MRI SURESCAN IPG AND PACING SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S220
- Product code
- LWP
- Decision date
- 2016-08-24
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for the expansion of MRI conditional labeling for the Amplia MRI and Compia MRI Systems to include 3T MRI.
Current openFDA PMA Record#
- Device
- REVO MRI SURESCAN IPG AND PACING SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S220
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-08-24
- Decision code
- APPR
- Date received
- 2016-03-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the expansion of MRI conditional labeling for the Amplia MRI and Compia MRI Systems to include 3T MRI.