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

FDA premarket approval P150031/S027 · decided 2019-12-04

Approval details

PMA number
P150031
Supplement
S027
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
2019-11-06
Decision date
2019-12-04
Days to decision
28 days
Decision code
OK30
Product code
NHL
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Increase the maximum proximal end backfill cure time from 4 hours to 48 hours for its Leads and Lead Extension for the Vercise, Vercise PC, and Vercise Gevia VNS Systems.

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