PMA P150031S094

Device
Vercise Deep Brain Stimulation (DBS) Systems
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S094
Product code
NHL
Decision date
2026-05-18
Classification
Neurology
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement
approval to utilize an alternate cleaning solvent to clean the gold preforms

Current openFDA PMA Record#

Device
Vercise Deep Brain Stimulation (DBS) Systems
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S094
Product code
NHL
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date
2026-05-18
Decision code
OK30
Date received
2026-05-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval to utilize an alternate cleaning solvent to clean the gold preforms