Pain PC (Vanta with AdaptiveStim , and Sequentia LT) Implantable Neurostimulation Systems and Pisces, Specify, and Ve
FDA premarket approval P840001/S471 · decided 2021-06-09
Approval details
- PMA number
- P840001
- Supplement
- S471
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Pain PC (Vanta with AdaptiveStim , and Sequentia LT) Implantable Neurostimulation Systems and Pisces, Specify, and Ve
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2020-09-04
- Decision date
- 2021-06-09
- Days to decision
- 278 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for 1) the Pain PC System for Spinal Cord Stimulation (SCS) which includes Implantable Neurostimulation Systems Vanta with AdaptiveStim and Sequentia LT; and 2) modified labeling for the Model B31060 Connector Plug to reflect its intended use with the Pain PC system. 3) labeling updates for previously approved devices to be consistent with Pain PC system labeling.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |