Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord
FDA premarket approval P840001/S586 · decided 2024-12-23
Approval details
- PMA number
- P840001
- Supplement
- S586
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2024-12-09
- Decision date
- 2024-12-23
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- approval for manufacturing updates of metal strip resistors manufactured at Vishay Thin Film, an external supplier to Medtronics internal supplier Medtronic Tempe Campus (MTC). The supplier requested updates include use of an existing sample preparation method, and a tolerance change on a negligible risk level feature for manufacturability
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |