SPINAL CORD STIMULATION (ITREL SYNERGY, SYNERGY VERSITREL, RESTOREPRIME, RESTORE ADVANCED, PRIME ADVANCED RESTOR ULTRA,
FDA premarket approval P840001/S235 · decided 2013-06-17
Approval details
- PMA number
- P840001
- Supplement
- S235
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPINAL CORD STIMULATION (ITREL SYNERGY, SYNERGY VERSITREL, RESTOREPRIME, RESTORE ADVANCED, PRIME ADVANCED RESTOR ULTRA,
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2013-02-08
- Decision date
- 2013-06-17
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A CHANGE TO A SOFTWARE-BASED SYSTEM FOR INCOMING INSPECTION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |