MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM
FDA premarket approval P970004/S033 · decided 2006-06-30
Approval details
- PMA number
- P970004
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2005-09-30
- Decision date
- 2006-06-30
- Days to decision
- 273 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INTERSTIM NEUROSTIMULATOR (MODEL 3058 INTERSTIM II), PATIENT PROGRAMMER (MODEL 3037 ICON), THERAPY APPLICATION SOFTWARE, TINED LEADS (MODELS 3889/3093), SYSTEM ACCESSORIES (MODEL 37092 EXTERNAL ANTENNA, TORQUE HEX WRENCH, TUNNELING TOOL), AND LABELING ARCHITECTURE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |