InterStim Therapy System and Verify Evaluation System
FDA premarket approval P970004/S326 · decided 2020-12-16
Approval details
- PMA number
- P970004
- Supplement
- S326
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System and Verify Evaluation System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2020-11-19
- Decision date
- 2020-12-16
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- 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 |