PMA P080025S165
- Device
- InterStim Therapy System, Verify Evaluation System (Bowel)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S165
- Product code
- QON
- Decision date
- 2018-05-24
- Classification
- Stimulator, Electrical, Implantable, For Incontinence
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- Dimensional change, a dimensional system change, and a clarification of design intent on specifications for the manufacture and inspection of the Patient Programmers in response to complaints of battery compartment heating.
Current openFDA PMA Record#
- Device
- InterStim Therapy System, Verify Evaluation System (Bowel)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S165
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2018-05-24
- Decision code
- OK30
- Date received
- 2018-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Dimensional change, a dimensional system change, and a clarification of design intent on specifications for the manufacture and inspection of the Patient Programmers in response to complaints of battery compartment heating.