Master Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal C
FDA premarket approval P840001/S499 · decided 2022-05-13
Approval details
- PMA number
- P840001
- Supplement
- S499
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Master Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal C
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-08-30
- Decision date
- 2022-05-13
- Days to decision
- 256 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the Model EMBSNV20 BSNV-8 1x8 Adaptor Extension and a minor configuration change to previously approved software devices: Model A710 Intellis Clinician Programmer Application and Model A71200 Vanta/Sequentia LT Clinician Programmer Application.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |