PMA P090013S248
- Device
- CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S248
- Product code
- LWP
- Decision date
- 2017-04-25
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for 1.5 and 3T MR Conditional labeling for MRI SureScan Lead Model 6946M.
Current openFDA PMA Record#
- Device
- CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S248
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-04-25
- Decision code
- APPR
- Date received
- 2017-01-25
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for 1.5 and 3T MR Conditional labeling for MRI SureScan Lead Model 6946M.