FDA.reportPublic FDA data

PMA P150031S038

Device
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) System
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S038
Product code
NHL
Decision date
2020-08-14
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement
Add an alternate qualified supplier for the surgical tool components of the SureTek Burr Hole Cover Kit, which are used during the deep brain stimulation (DBS) procedure for the Vercise, Vercise PC, and Vercise Gevia DBS Systems.

Current openFDA PMA Record#

Device
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) System
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S038
Product code
NHL
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date
2020-08-14
Decision code
OK30
Date received
2020-07-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add an alternate qualified supplier for the surgical tool components of the SureTek Burr Hole Cover Kit, which are used during the deep brain stimulation (DBS) procedure for the Vercise, Vercise PC, and Vercise Gevia DBS Systems.