INTERSTIM THERAPY: TORQUE WRENCH AND BOOK KIT, MODEL 3550-80
FDA premarket approval P970004/S056 · decided 2008-07-03
Approval details
- PMA number
- P970004
- Supplement
- S056
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERSTIM THERAPY: TORQUE WRENCH AND BOOK KIT, MODEL 3550-80
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2008-05-12
- Decision date
- 2008-07-03
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE ADDITION OF CONVENIENCE KIT (MODEL 3550-80) WHICH INCLUDES A TORQUE WRENCH AND BOOT CONNECTOR.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |