- Device
- InterStim Therapy System and Verify Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S221
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2020-12-16
- Decision code
- OK30
- Date received
- 2020-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.