INTERSTIM SACRAL NERVE STIMULATION SYSTEM
FDA premarket approval P970004/S010 · decided 2000-06-28
Approval details
- PMA number
- P970004
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERSTIM SACRAL NERVE STIMULATION SYSTEM
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2000-06-20
- Decision date
- 2000-06-28
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR 1) INCLUSION OF DEPTH INDICATORS ALONG THE BODY OF THE MODEL 3057 TEST STIMULATION LEAD AND ASSOCIATED LABELING CHANGES (3057 TEST STIMULATION COMPONENTS MANUAL AND 3065U MANUAL), AND 2) OTHER MINOR LABELING CHANGES TO THESE MANUALS FOR CLARIFICATION OF INSTRUCTIONS AND MINOR REFINEMENTS TO THE LEAD TESTING SPECIFICATIONS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |