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

FDA premarket approval P150031/S029 · decided 2020-03-17

Approval details

PMA number
P150031
Supplement
S029
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
2020-02-20
Decision date
2020-03-17
Days to decision
26 days
Decision code
OK30
Product code
NHL
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Alternate EO sterilization cycle and upgraded sterilization equipment to sterilize all sterile products and accessories of the DBS Systems, except for the Burr Hole Cover Kit.

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510(k) clearances by this applicant

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