INTERSTIM THERAPY SYSTEM
FDA premarket approval P970004/S204 · decided 2015-12-21
Approval details
- PMA number
- P970004
- Supplement
- S204
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTERSTIM THERAPY SYSTEM
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2015-08-31
- Decision date
- 2015-12-21
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGES TO THE H2 CATHODE MIX PROCESS USED TO MANUFACTURE BATTERIES FOR IMPLANTABLE DEVICES.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |