InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems)
FDA premarket approval P970004/S322 · decided 2021-02-02
Approval details
- PMA number
- P970004
- Supplement
- S322
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2020-11-04
- Decision date
- 2021-02-02
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for minor labeling changes to the MRI Guidelines for InterStim systems manual for the InterStim Micro and InterStim II systems used for Sacral Neuromodulation (SNM) therapy to treat urinary retention and the symptoms of overactive bladder, and chronic fecal incontinence.
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 |