MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL STIMULATON DESKTOP SOFTWARE
FDA premarket approval P970004/S023 · decided 2003-01-23
Approval details
- PMA number
- P970004
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL STIMULATON DESKTOP SOFTWARE
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2002-07-31
- Decision date
- 2003-01-23
- 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 8870 INTERSTIM APPLICATION SOFTWARE TO OPERATING ON THE MODEL 8840 CLINICIAN PROGRAMMER, USE OF ENHANCED STIMULATION DESKTOP SOFTWARE, AN EXPANDED MEMORY CARD STORAGE, AND UPDATED LABELING. THESE CHANGES ARE USED 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, I
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| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |