INTERSTIM THERAPY FOR URINARY CONTROL
FDA premarket approval P970004/S013 · decided 2001-08-17
Approval details
- PMA number
- P970004
- Supplement
- S013
- 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
- 2001-02-22
- Decision date
- 2001-08-17
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE MODEL 3550-03 TWIST-LOCK SCREENING CABLE AND MODEL 3550-05 PERCUTANEOUS EXTENSION AND TUNNELING TOOL KIT FOR TEMPORARY SACRAL NERVE STIMULATION AS PART OF A STAGED IMPLANT TECHNIQUE FOR THE MEDTRONIC(R) INTERSTIM(R) THERAPY FOR URINARY CONTROL, WHICH IS INDICATED FOR THE TREATMENT OF URINARY URGE INCONTINENCE, URINARY RETENTION, AND SIGNIFICANT SYMPTOMS OF URGENCY-FREQUENCY 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 |