Master Restore, Itrel, Synergy and lntellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord
FDA premarket approval P840001/S514 · decided 2022-07-21
Approval details
- PMA number
- P840001
- Supplement
- S514
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Master Restore, Itrel, Synergy and lntellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2022-04-22
- Decision date
- 2022-07-21
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for an update to the primary Information for Prescribers (IFP) clinician labeling, and update to the primary Patient Therapy Guide (PTG).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |