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

FDA premarket approval P150031/S015 · decided 2019-03-19

Approval details

PMA number
P150031
Supplement
S015
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) System
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Applicant
Boston Scientific Corp
Date received
2019-02-19
Decision date
2019-03-19
Days to decision
28 days
Decision code
OK30
Product code
NHL
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Adding an alternate qualified supplier (Heraeus) for the cables used in the Deep Brain Stimulation (DBS) Leads, which include the standard DBS Leads and the Vercise Cartesia DBS Directional Leads.

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510(k) clearances by this applicant

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