PMA P090013S288
- Device
- Revo MRI SureScan IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S288
- Product code
- LWP
- Decision date
- 2018-10-03
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for labeling updates to the clinical study summary for the post approval study.
Current openFDA PMA Record#
- Device
- Revo MRI SureScan IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S288
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-10-03
- Decision code
- APPR
- Date received
- 2018-06-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling updates to the clinical study summary for the post approval study.