PMA P960009S528

Device: DBS Implantable Neurostimulator Models B35200, B35300; DBS Implantable Neurostimulators Activa Family Models 37601, 3760
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S528
Product code: MHY
Decision date: 2026-02-12
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
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: DBS Implantable Neurostimulator Models B35200, B35300; DBS Implantable Neurostimulators Activa Family Models 37601, 3760
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S528
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
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.