Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal Cord Sti
FDA premarket approval P840001/S497 · decided 2021-10-26
Approval details
- PMA number
- P840001
- Supplement
- S497
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal Cord Sti
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-07-28
- Decision date
- 2021-10-26
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for minor labeling changes for the Models 97715 and 97716 Intellis implantable neurostimulators, Model 977Axxx and 977Dxxx Vectris lead kits, Model 977Cxxx Specify lead kits, and Model 9779x Injex anchor accessory kits which includes removing storage temperature limits from the labeling.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |