InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems)
FDA premarket approval P970004/S332 · decided 2021-04-09
Approval details
- PMA number
- P970004
- Supplement
- S332
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems)
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-03-11
- Decision date
- 2021-04-09
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Addition of a test application to the DistributionCenter Sorter Tool (DCST) for Model 97810 InterStim Micro.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |