InterStim Therapy System, Verify Evaluation System
FDA premarket approval P080025/S157 · decided 2017-12-13
Approval details
- PMA number
- P080025
- Supplement
- S157
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System, Verify Evaluation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-11-13
- Decision date
- 2017-12-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Transfer of the injection molding of the TIP-QUAD LEAD, part number 117167001, from Medtronic Energy and Component Center (MECC) to Donatelle Plastics, Inc.
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 |