PMA P080025S190
- Device
- InterStim Therapy System, Verify Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S190
- Product code
- QON
- Decision date
- 2019-08-14
- Classification
- Stimulator, Electrical, Implantable, For Incontinence
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- Use of newer test instrumentation for testing the electrolyte material and for updates to the test method used for the testing.
Current openFDA PMA Record#
- Device
- InterStim Therapy System, Verify Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S190
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2019-08-14
- Decision code
- OK30
- Date received
- 2019-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of newer test instrumentation for testing the electrolyte material and for updates to the test method used for the testing.