SPECIFY SURESCAN MRI 5-6-5 LEAD 65 CM, SPECIFY SURESCAN MRI 5-6-5 LEAD 90 CM, SPECIFY SURESCAN MRI 2X8 LEAD 65 CM, SPECI
FDA premarket approval P840001/S308 · decided 2016-02-05
Approval details
- PMA number
- P840001
- Supplement
- S308
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPECIFY SURESCAN MRI 5-6-5 LEAD 65 CM, SPECIFY SURESCAN MRI 5-6-5 LEAD 90 CM, SPECIFY SURESCAN MRI 2X8 LEAD 65 CM, SPECI
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2015-06-19
- Decision date
- 2016-02-05
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the Specify SureScan MRI 5-6-5 and 2x8 surgical lead kits.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |