PMA P150031S063

Device
Vercise Deep Brain Stimulation (DBS) Systems
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S063
Product code
NHL
Decision date
2023-10-25
Classification
Neurology
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement
approval for the current supplier of the rechargeable Lithium-Ion batteries to move to its new manufacturing facility

Current openFDA PMA Record#

Device
Vercise Deep Brain Stimulation (DBS) Systems
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S063
Product code
NHL
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date
2023-10-25
Decision code
OK30
Date received
2023-09-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for the current supplier of the rechargeable Lithium-Ion batteries to move to its new manufacturing facility