INTERSTIM THERAPY
FDA premarket approval P970004/S141 · decided 2012-11-01
Approval details
- PMA number
- P970004
- Supplement
- S141
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- INTERSTIM THERAPY
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2012-09-06
- Decision date
- 2012-11-01
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |