Master Restore, Itrel, Synergy and IntellisM Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cor
FDA premarket approval P840001/S419 · decided 2019-03-08
Approval details
- PMA number
- P840001
- Supplement
- S419
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Master Restore, Itrel, Synergy and IntellisM Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cor
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2018-12-26
- Decision date
- 2019-03-08
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a change in material purity of niobium wire stock; second-tier raw material supplier change for niobium wire stock; lubricant change for wire drawing process; and process change to anneal wire prior to wire drawing process.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |