InterStim, Therapy System, Verify Evaluation System (SNS Urinary Lead)
FDA premarket approval P970004/S265 · decided 2018-06-02
Approval details
- PMA number
- P970004
- Supplement
- S265
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim, Therapy System, Verify Evaluation System (SNS Urinary Lead)
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2018-01-05
- Decision date
- 2018-06-02
- Days to decision
- 148 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for adding an alternate supplier to manufacture the coil components used in the implanted leads of the Deep Brain Stimulator (DBS), Spinal Cord Stimulation (SCS), and Sacral Nerve Stimulation (SNS) devices.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |