INTERSTIM SACRAL NERVE STIMULATION SYSTEM
FDA premarket approval P970004/S009 · decided 2000-10-18
Approval details
- PMA number
- P970004
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERSTIM SACRAL NERVE STIMULATION SYSTEM
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2000-04-21
- Decision date
- 2000-10-18
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE MODEL 3095A LEAD EXTENSION KIT FOR USE WITH THE MEDTRONIC(R) INTERSTIM(R) SYSTEM FOR URINARY CONTROL, WHICH IS INDICATED FOR THE TREATMENT OF URINARY URGE INCONTINENCE, URINARY RETENTION, AND SIGNIFICANT SYMPTOMS OF URGENCY/FREQUENDY IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |