Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
FDA premarket approval P840001/S475 · decided 2021-01-29
Approval details
- PMA number
- P840001
- Supplement
- S475
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2020-11-02
- Decision date
- 2021-01-29
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a design change to the battery cells, which is packaged with the external Model 97755 Intellis Recharger, with a reduced current output from 1760 mA to 1600 mA and different geometry requiring a thicker battery pack which requires to have a battery compartment cover to be included with the Model 97755 Recharger to fit over the new battery pack when inserted on the Model 97745 Controller.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |