Restore, Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal Cord S
FDA premarket approval P840001/S486 · decided 2021-06-07
Approval details
- PMA number
- P840001
- Supplement
- S486
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Restore, Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal Cord S
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-03-22
- Decision date
- 2021-06-07
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a change to Model 977D160 Vectris® 1x8 SC (Subcompact) Trial Screening Lead and Model 977D260 Vectris® 1x8 Compact Trial Screening Lead, to add an alternate material, 304 stainless-steel wire, for the braided shield of the Vectris lead body.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |