INTERSTIM THERAPY FOR URINARY CONTROL
FDA premarket approval P970004/S005 · decided 1999-09-03
Approval details
- PMA number
- P970004
- Supplement
- S005
- Supplement type
- Real-Time Process
- 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
- 1999-08-25
- Decision date
- 1999-09-03
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for an alternate insulation material for the Medtronic(R) Model 3057 Temporary Test Stimulation Lead.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |