PMA P960009S405
- Device
- SenSight™ Directional Lead Kit, SenSight™ Extension Kit
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S405
- Product code
- MHY
- Decision date
- 2021-08-20
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- Update the monitoring process for the SenSight Directional Leads and SenSight Extensions.
Current openFDA PMA Record#
- Device
- SenSight™ Directional Lead Kit, SenSight™ Extension Kit
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S405
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 2021-08-20
- Decision code
- OK30
- Date received
- 2021-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the monitoring process for the SenSight Directional Leads and SenSight Extensions.