Restore Spinal Cord Stimulation Systems
FDA premarket approval P840001/S356 · decided 2017-04-25
Approval details
- PMA number
- P840001
- Supplement
- S356
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore Spinal Cord Stimulation Systems
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-04-03
- Decision date
- 2017-04-25
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Additions to the Argon Gas Resistant Spot Welding (RSW) manufacturing process to ensure proper setup and the availability of Argon Gas at Medtronics internal supplier, Medtronic Energy and Component Center (MECC).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |