InterStim Therapy System, Verify Evaluation System (Bowel)
FDA premarket approval P080025/S165 · decided 2018-05-24
Approval details
- PMA number
- P080025
- Supplement
- S165
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System, Verify Evaluation System (Bowel)
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2018-04-26
- Decision date
- 2018-05-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Dimensional change, a dimensional system change, and a clarification of design intent on specifications for the manufacture and inspection of the Patient Programmers in response to complaints of battery compartment heating.
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 |