Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul
FDA premarket approval P840001/S482 · decided 2021-02-24
Approval details
- PMA number
- P840001
- Supplement
- S482
- 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
- 2020-12-21
- Decision date
- 2021-02-24
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for change in A710 software to version 1.3.130 from version 1.3.80 to correct software code to ensure Model A710 Intellis Clinician Programmer Application (CP App) for Mobile Platform resets invalid data to resolve the memory block validation error.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |