RESTORE ADVANCED & PRIME ADVANCED NEUROSTIMULATIONS SYSTEMS
FDA premarket approval P840001/S092 · decided 2006-07-07
Approval details
- PMA number
- P840001
- Supplement
- S092
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESTORE ADVANCED & PRIME ADVANCED NEUROSTIMULATIONS SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2006-05-12
- Decision date
- 2006-07-07
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE RESTOREADVANCED AND PRIME ADVANCED NEUROSTIMULATION SYSTEMS. THE DEVICES ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: 1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME; 3) POST LAMINECTOMY PAIN; 4) UNSUCCESSFUL DISK SURGERY; 5) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY T
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |