PMA P080025S339

Device: SNS Bowel Neurostimulator Models 97800, 97810; SNS Bowel Screening Trialing System Model 3531
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S339
Product code: QON
Decision date: 2026-02-12
Classification: Gastroenterology, Urology
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Approval for die-level traceability implementation and substrate e-Mark process improvement at a sub-tier supplier for Stack Chip Scale Package (SCSP) components.

Current openFDA PMA Record#

Device: SNS Bowel Neurostimulator Models 97800, 97810; SNS Bowel Screening Trialing System Model 3531
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S339
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2026-02-12
Decision code: OK30
Date received: 2026-01-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for die-level traceability implementation and substrate e-Mark process improvement at a sub-tier supplier for Stack Chip Scale Package (SCSP) components.