Atlas FDA

Vercise Deep Brain Stimulation Systems

FDA premarket approval P150031/S043 · decided 2021-06-02

Approval details

PMA number
P150031
Supplement
S043
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Vercise Deep Brain Stimulation Systems
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Applicant
Boston Scientific Corp
Date received
2021-05-24
Decision date
2021-06-02
Days to decision
9 days
Decision code
OK30
Product code
NHL
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Update the Implantable Pulse Generator (IPG) Automatic Test Equipment (ATE) software to clear the manufacturing data logs created during the Printed Circuit Board assembly (PCBA) manufacturing process at the Boston Scientific Clonmel manufacturing site

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