MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM
FDA premarket approval P970004/S002 · decided 1998-07-08
Approval details
- PMA number
- P970004
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 1998-02-27
- Decision date
- 1998-07-08
- Days to decision
- 131 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for marketing the Medtronic InterStim(R) Model 3023 Implantable Pulse Generator (IPG) and its control devices (model 3031 Patient Programmer with Model 7440 Optional antenna and Model 3051 Software Cartridge Memory Module (MemMod(R)) and is indicated for the treatment of urinary urge incontinence 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 |