PMA P080025S219
- Device
- InterStim SureScan MRI Leads and Percutaneous Extensions
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S219
- Product code
- QON
- Decision date
- 2020-12-16
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- additional manufacturing equipment
Current openFDA PMA Record#
- Device
- InterStim SureScan MRI Leads and Percutaneous Extensions
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S219
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2020-12-16
- Decision code
- OK30
- Date received
- 2020-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- additional manufacturing equipment