INTERSTIM THERAPY SYSTEM
FDA premarket approval P970004/S202 · decided 2015-07-16
Approval details
- PMA number
- P970004
- Supplement
- S202
- Supplement type
- 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
- 2015-06-17
- Decision date
- 2015-07-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- MANUFACTURING CHANGE TO EXPAND THE UPPER LIMIT OF THE TEMPERATURE RANGE FOR THE CONDITIONING PHASE OF THE STANDARD STERILIZATION CYCLE AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |