Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads
FDA premarket approval P840001/S345 · decided 2016-11-28
Approval details
- PMA number
- P840001
- Supplement
- S345
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2016-11-03
- Decision date
- 2016-11-28
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Changes to the integrated circuit wafer manufacturing process flow for the 1.5µm High-density (HD) Bipolar and Complementary Metal Oxide Semiconductor (BiCMOS) at the Singapore AMK6 fabrication facility of Medtronics supplier, STMicroelectronics.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |