Restore, Intrel and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead
FDA premarket approval P840001/S365 · decided 2017-09-01
Approval details
- PMA number
- P840001
- Supplement
- S365
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Restore, Intrel and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-06-07
- Decision date
- 2017-09-01
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a minor design change (lowering values of resistances R54 and R56 in the analog board of the INSR) to the Implantable Neurostimulator Recharger (INSR) used in the Restore Spinal Cord Stimulation and Activa Deep Brain Stimulation therapy systems.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |