NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (SCS)
FDA premarket approval P840001/S267 · decided 2014-04-30
Approval details
- PMA number
- P840001
- Supplement
- S267
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (SCS)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2014-03-31
- Decision date
- 2014-04-30
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL TO PROVIDE CORRECTIONS TO THE LABELING RELATED TO THE CYCLING FEATURE (ALTERNATING BETWEEN THERAPY OFF AND ON) IN SOME NEUROSTIMULATION DEVICES USED FOR SPINAL CORD STIMULATION AND DEEP BRAIN STIMULATION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |