Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord
FDA premarket approval P840001/S390 · decided 2018-06-02
Approval details
- PMA number
- P840001
- Supplement
- S390
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2018-01-05
- Decision date
- 2018-06-02
- Days to decision
- 148 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for adding an alternate supplier to manufacture the coil components used in the implanted leads of the Deep Brain Stimulator (DBS), Spinal Cord Stimulation (SCS), and Sacral Nerve Stimulation (SNS) devices.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |