InterStim Therapy System and Verify Evaluation System
FDA premarket approval P080025/S221 · decided 2020-12-16
Approval details
- PMA number
- P080025
- Supplement
- S221
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System and Verify Evaluation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2020-11-19
- Decision date
- 2020-12-16
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- the proposed transfer of manufacturing activities of the lead assembly to the Heraeus Costa Rica manufacturing facility and minor manufacturing equipment changes at the facility to support the proposed transfer. Also, changes to a processing aid used during the manufacturing process of the material that is used at Heraeus Medical Components to coat the lead assembly.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |