INTERSTIM THERAPY FOR URINARY CONTROL
FDA premarket approval P970004/S021 · decided 2002-02-15
Approval details
- PMA number
- P970004
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTERSTIM THERAPY FOR URINARY CONTROL
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2002-01-17
- Decision date
- 2002-02-15
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE REVISED INDICATION: "INTERSTIM THERAPY FOR URINARY CONTROL 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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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |