RESTORESENSOR RECHARGABLE IMPLANTABLE NEUROSTIMULATION SYSTEM
FDA premarket approval P840001/S185 · decided 2011-11-03
Approval details
- PMA number
- P840001
- Supplement
- S185
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESTORESENSOR RECHARGABLE IMPLANTABLE NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2011-05-16
- Decision date
- 2011-11-03
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE RESTORESENSOR RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RESTORESENSOR RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM AND IS INDICATED FOR SPINAL CORD STIMULATION (SCS) AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING CONDITIONS:1) FAILED BACK SYNDROME (FBS) OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR
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| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |