INTERSTIM THERAPY SYSTEM
FDA premarket approval P970004/S098 · decided 2011-01-11
Approval details
- PMA number
- P970004
- Supplement
- S098
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERSTIM THERAPY SYSTEM
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2010-11-12
- Decision date
- 2011-01-11
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MINOR LABELING CHANGES TO THE MODEL 8840/ 8870 PROGRAMMING GUIDE TO MITIGATE THE EFFECTS OF THE OBSERVED LOCKING OF THE CLINICIAN PROGRAMMER¿S INFRARED COMMUNICATION PORT AFTER PRINTING PROGRAMMING SESSION REPORTS.
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| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |