PMA P150031S049

Device
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System
Applicant
Boston Scientific Corp
Product code
NHL
Decision date
2022-10-27
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement
Approval of the addition of the 2x8 Contact Lead Extensions.

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
S049
Product code
NHL
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date
2022-10-27
Decision code
APPR
Date received
2022-04-05
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval of the addition of the 2x8 Contact Lead Extensions.