PERCUTANEOUS EXTENSION KIT
FDA premarket approval P840001/S236 · decided 2016-12-06
Approval details
- PMA number
- P840001
- Supplement
- S236
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PERCUTANEOUS EXTENSION KIT
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2013-02-11
- Decision date
- 2016-12-06
- Days to decision
- 1394 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for changing the tubing material from the prior MDX silicone resin to the NuSil MED 4719 silicone resin.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |