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Vercise Genus™ DBS Systems, Vercise Gevia™ DBS System, Vercise™ PC DBS System

FDA premarket approval P150031/S060 · decided 2023-10-10

Approval details

PMA number
P150031
Supplement
S060
Supplement type
Real-Time Process
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Vercise Genus™ DBS Systems, Vercise Gevia™ DBS System, Vercise™ PC DBS System
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Applicant
Boston Scientific Corp
Date received
2023-08-30
Decision date
2023-10-10
Days to decision
41 days
Decision code
APPR
Product code
NHL
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
approval for change of Tungsten Stylet supplier, change of stylet handle design, and change of source for Polytetrafluoroethylene coating.

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