SNS URINARY ACCESSORIES,SNS URINARY EXTENSIONS,SNS URINARY LEADS,SNS URINARY NEUOSTIMULATOR IMPLANTABLE INTERSTIM FAMILY
FDA premarket approval P970004/S147 · decided 2013-01-08
Approval details
- PMA number
- P970004
- Supplement
- S147
- 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 NEUOSTIMULATOR IMPLANTABLE INTERSTIM FAMILY
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2012-12-11
- Decision date
- 2013-01-08
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- USE AN UPDATED VERSION OF THE SOFTWARE ALREADY IN USE AT VARIOUS FACILITIES TO ENSURE COMPLIANCE TO TRAINING REQUIREMENTS, PROPER DOCUMENTATION ASSOCIATED WITH DISPOSITION OF PRODUCT, AND PROPER FUNCTION OF THE SOFTWARE BY CORRECTING MINOR ISSUES PRESENT IN THE CURRENT SOFTWARE VERSION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |