PMA P150031S065

Device: Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System
Applicant: Boston Scientific Corp
Product code: NHL
Decision date: 2024-11-13
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement: which requested approval for the following: Vercise Cartesia X Directional Lead Kits (Models DB-2203-30B and DB-2203-45B), Vercise Cartesia HX 16-contact Directional Lead Kits (Models DB-2204-30B and DB-2204-45B), 16-contact Lead Extension Kits (Models DB-3216-55 and DB-3216-95), 2x8 Lead Extension Kits (Models DB-3128 and DB-3128-95), and Vercise Physicians Spare Kit (Model DB-2501).

Current openFDA PMA Record

Device: Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S065
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2024-11-13
Decision code: APPR
Date received: 2023-09-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: which requested approval for the following: Vercise Cartesia X Directional Lead Kits (Models DB-2203-30B and DB-2203-45B), Vercise Cartesia HX 16-contact Directional Lead Kits (Models DB-2204-30B and DB-2204-45B), 16-contact Lead Extension Kits (Models DB-3216-55 and DB-3216-95), 2x8 Lead Extension Kits (Models DB-3128 and DB-3128-95), and Vercise Physicians Spare Kit (Model DB-2501).