RESTORE PRIME, PRIMEADVANCED, RESTORE RECHARGEABLE, RESTORE ADVANCED AND RECHARGEABLE MODELS
FDA premarket approval P840001/S126 · decided 2009-06-03
Approval details
- PMA number
- P840001
- Supplement
- S126
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RESTORE PRIME, PRIMEADVANCED, RESTORE RECHARGEABLE, RESTORE ADVANCED AND RECHARGEABLE MODELS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2008-12-24
- Decision date
- 2009-06-03
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MODEL 39565 SPECIFY 5-6-5 LEAD KIT (65CM LENGTH), MODEL 39286 SPECIFY 2X8 SURGICAL LEAD KIT (30CM AND 65CM LENGTHS), AND MODEL 3550-P4 PASSING ELEVATOR ACCESSORY KIT.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |