SNS Urinary Accessories SNS Urinary Extensions SNS Urinary Leads SNS Urinary Neurostimulator 3023,3058 SNS Urinary Progr
FDA premarket approval P970004/S231 · decided 2016-12-13
Approval details
- PMA number
- P970004
- Supplement
- S231
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SNS Urinary Accessories SNS Urinary Extensions SNS Urinary Leads SNS Urinary Neurostimulator 3023,3058 SNS Urinary Progr
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2016-11-14
- Decision date
- 2016-12-13
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Update of the manufacturing execution system (MES) to FACTORYworks (FW) Release 9.3.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |