MEDTRONIC INTERSTIM TINED LEAD MODELS 3889 & 3093
FDA premarket approval P970004/S040 · decided 2007-10-23
Approval details
- PMA number
- P970004
- Supplement
- S040
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MEDTRONIC INTERSTIM TINED LEAD MODELS 3889 & 3093
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2007-01-12
- Decision date
- 2007-10-23
- Days to decision
- 284 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |