MEDTRONIC NEUROSTIMULATION SYSTEMS (RESTORE, SYNERGY, SYNERGY VERSITREL, SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+)
FDA premarket approval P840001/S088 · decided 2006-01-26
Approval details
- PMA number
- P840001
- Supplement
- S088
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC NEUROSTIMULATION SYSTEMS (RESTORE, SYNERGY, SYNERGY VERSITREL, SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2005-11-30
- Decision date
- 2006-01-26
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A MODIFICATION OF THE MODEL 37742 PATIENT PROGRAMMER TO ALLOW PATIENTS TO RESET A POWER-ON-RESET (POR) STATUS OF THE EXTERNAL NEUROSTIMULATOR TO THE PHYSICIAN PROGRAMMED SETTINGS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |