PMA P080025S094
- Device
- INTERSTIM THERAPY SYSTEM
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S094
- Product code
- QON
- Decision date
- 2015-07-01
- Classification
- Stimulator, Electrical, Implantable, For Incontinence
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- CHANGES TO INCREASE SAMPLE SIZE FOR H2 PYCNOMETRY TEST.
Current openFDA PMA Record#
- Device
- INTERSTIM THERAPY SYSTEM
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S094
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2015-07-01
- Decision code
- OK30
- Date received
- 2015-06-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO INCREASE SAMPLE SIZE FOR H2 PYCNOMETRY TEST.