PMA P150031

Device: VERCISE DEEP BRAIN STIMULATION (DBS) SYSTEM
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S054
Product code: NHL
Decision date: 2026-09-13
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: approval for MRI guidelines labeling updates to include the Vercise Cartesia X and HX 16-contact Directional Leads, 16-contact Lead Extensions, and 8x2-contact Lead extensions of the Vercise Genus DBS System to the configurations approved for 1.5T MRI scans.

Current openFDA PMA Record#

Device: VERCISE DEEP BRAIN STIMULATION (DBS) SYSTEM
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S084
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2026-09-13
Decision code: APPR
Date received: 2025-04-03
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for MRI guidelines labeling updates to include the Vercise Cartesia X and HX 16-contact Directional Leads, 16-contact Lead Extensions, and 8x2-contact Lead extensions of the Vercise Genus DBS System to the configurations approved for 1.5T MRI scans.