RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RETSOREADVANCED/EXTERNAL NEUROSTIMULAR INS
FDA premarket approval P840001/S184 · decided 2011-11-09
Approval details
- PMA number
- P840001
- Supplement
- S184
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RETSOREADVANCED/EXTERNAL NEUROSTIMULAR INS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2011-04-18
- Decision date
- 2011-11-09
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A MODIFICATION TO A CLEANING PROCESS FOR HYBRID COMPONENTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |