InterStim Therapy System, Verify Evaluation System (SNS Urinary)
FDA premarket approval P970004/S321 · decided 2020-11-30
Approval details
- PMA number
- P970004
- Supplement
- S321
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System, Verify Evaluation System (SNS Urinary)
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2020-11-03
- Decision date
- 2020-11-30
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Addition of Meier Tool & Engineering (Meier Tool), Anoka, MN - USA as an alternate supplier for a battery component (second source) for the uncoated battery cathode current collector that is consumed into titanium coated cathode current collectors and eventually into the Delta 26H2 and Delta 26H3 medium rate batteries further used in implantable neurostimulators. And the addition of Incoming Inspection Procedures for Uncoated and Coated Cathode Current Collector Components Originating from Meier
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |