- Device
- InterStim Therapy System and Verify Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S326
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for 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
- 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.