Master Restore Spinal Cord Stimulation Systems, Itrel® Spinal Cord Stimulation Systems, Synergy® Spinal Cord Stimulation
FDA premarket approval P840001/S564 · decided 2024-05-23
Approval details
- PMA number
- P840001
- Supplement
- S564
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Master Restore Spinal Cord Stimulation Systems, Itrel® Spinal Cord Stimulation Systems, Synergy® Spinal Cord Stimulation
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2024-05-17
- Decision date
- 2024-05-23
- Days to decision
- 6 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- approval for the updates to the Delta 26H battery header tooling and associated processes in routine battery manufacturing at Medtronics internal supplier of batteries, Medtronic Energy and Component Center (MECC), Brooklyn Center, Minnesota
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |