PMA P090013S298
- Device
- CapSureFix MRI Surescan Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S298
- Product code
- LWP
- Decision date
- 2019-05-30
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
Current openFDA PMA Record#
- Device
- CapSureFix MRI Surescan Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S298
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-05-30
- Decision code
- APPR
- Date received
- 2019-05-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS