Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces Specify, and Vectris Spinal Cord Stimulation Lead
FDA premarket approval P840001/S343 · decided 2016-09-28
Approval details
- PMA number
- P840001
- Supplement
- S343
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces Specify, and Vectris Spinal Cord Stimulation Lead
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2016-08-31
- Decision date
- 2016-09-28
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for updates to the labeling for the Medtronic Specify 5-6-5 and 2x8 surgical leads to clarify that these are not intended for test stimulation outside of the operating room.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |