INTERSTIM THERAPY FOR URINARY CONTROL
FDA premarket approval P970004/S022 · decided 2002-09-24
Approval details
- PMA number
- P970004
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERSTIM THERAPY FOR URINARY CONTROL
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2002-03-07
- Decision date
- 2002-09-24
- Days to decision
- 201 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR LEAD MODELS 3889 AND 3093 FOR USE WITH THE MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL, WHICH IS INDICATED FOR THE TREATMENT OF URINARY RETENTION AND THE SYMPTOMS OF OVERACTIVE BLADDER, INCLUDING URINARY URGE INCONTINENCE AND SIGNIFICANT SYMPTOMS OF URGENCY-FREQUENCY ALONE OR IN COMBINATION, IN PATIENTS WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE TREATMENTS.
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| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |