InterStim Therapy System and Verify Evaluation System (SNS Urinary)
FDA premarket approval P970004/S333 · decided 2021-06-22
Approval details
- PMA number
- P970004
- Supplement
- S333
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System and Verify Evaluation System (SNS Urinary)
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-05-27
- Decision date
- 2021-06-22
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Update the connector assembly resistance spot welding process window for the InterStim Micro INS (model 97810) at the Medtronics manufacturing facility located in Juncos, Puerto Rico.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |