PMA P970004S444

Device: SNS Urinary Neurostimulator Models 97800, 97810; SNS Urinary Screening Trialing Systems Model 3531
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S444
Product code: EZW
Decision date: 2026-02-12
Classification: Gastroenterology, Urology
Generic name: Stimulator, electrical, implantable, for 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 Urinary Neurostimulator Models 97800, 97810; SNS Urinary Screening Trialing Systems Model 3531
Applicant: Medtronic Neuromodulation
PMA number: P970004
Supplement: S444
Product code: EZW
Generic name: Stimulator, electrical, implantable, for 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.