PMA P080025S194
- Device
- InterStim Therapy System and Verify Evaluation System
- Applicant
- Medtronic Neuromodulation
- Product code
- QON
- Decision date
- 2019-11-26
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- Approval for an update to the inner packaging tray that holds the torque wrench.
Current openFDA PMA Record#
- Device
- InterStim Therapy System and Verify Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S194
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2019-11-26
- Decision code
- APPR
- Date received
- 2019-08-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an update to the inner packaging tray that holds the torque wrench.