Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu
FDA premarket approval P840001/S445 · decided 2019-10-23
Approval details
- PMA number
- P840001
- Supplement
- S445
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2019-09-23
- Decision date
- 2019-10-23
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for labeling changes to update existing Notes to Cautions and minor editorial changes for clarification and cross-therapy alignment purposes to the labeling for the; Spinal Cord Stimulation (SCS) Leads 1x8 Family, Injex Anchor Accessory Kits, Intellis Implantable Neurostimulation System for SCS, and SCS Screening Trial Leads.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |