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Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems

FDA premarket approval P150031/S018 · decided 2019-05-02

Approval details

PMA number
P150031
Supplement
S018
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Applicant
Boston Scientific Corp
Date received
2019-04-03
Decision date
2019-05-02
Days to decision
29 days
Decision code
OK30
Product code
NHL
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Expansion of Controlled Environmental Areas (CEA) for manufacturing of leads and accessories for the Vercise Deep Brain Stimulation (DBS) systems.

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