INTERSTIM LEADS
FDA premarket approval P080025/S024 · decided 2012-01-13
Approval details
- PMA number
- P080025
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTERSTIM LEADS
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2011-12-16
- Decision date
- 2012-01-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ADDITION OF TWO NEW DESKTOP WELDING STATIONS WITH UPDATED POWER SUPPLIES, AND TWO PROCESS CHANGES TO INCLUDE THE CONSOLIDATION OF PRODUCTION LASER WELD PROGRAM CODE AND REDUCING FREQUENCY PARAMETERS FOR THE WELDING PROCESS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |