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PMA P150031S062

Device
Vercise Genus DBS System
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S062
Product code
NHL
Decision date
2023-11-30
Classification
Neurology
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement
Your supplement requested approval for updates to the implanted pulse generator (IPG) firmware to delay time clock synchronization until charging is complete and replacing the capacitor C94, a 10 µF X7R capacitor, with a 22 µF X7R capacitor.

Current openFDA PMA Record#

Device
Vercise Genus DBS System
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S062
Product code
NHL
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date
2023-11-30
Decision code
APPR
Date received
2023-09-27
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Your supplement requested approval for updates to the implanted pulse generator (IPG) firmware to delay time clock synchronization until charging is complete and replacing the capacitor C94, a 10 µF X7R capacitor, with a 22 µF X7R capacitor.