INTERSTIM FOR URINARY CONTROL
FDA premarket approval P970004/S039 · decided 2006-06-27
Approval details
- PMA number
- P970004
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERSTIM FOR URINARY CONTROL
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2006-05-15
- Decision date
- 2006-06-27
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR SOFTWARE CHANGES TO THE MODEL 8840 N'VISION PROGRAMMING SYSTEM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |