PMA P080025S131
- Device
- MEDTRONIC INTERSTIM THERAPY SYSTEM (BOWEL)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S131
- Product code
- QON
- Decision date
- 2017-01-26
- Classification
- Stimulator, Electrical, Implantable, For Incontinence
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- New electrical discharge machining (EDM) equipment used during the manufacturing process of subcomponents for Medtronic Neuromodulation leads and extensions.
Current openFDA PMA Record#
- Device
- MEDTRONIC INTERSTIM THERAPY SYSTEM (BOWEL)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S131
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2017-01-26
- Decision code
- OK30
- Date received
- 2017-01-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New electrical discharge machining (EDM) equipment used during the manufacturing process of subcomponents for Medtronic Neuromodulation leads and extensions.