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

FDA Premarket Approval P150031 S029

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of an 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.

DeviceVercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems
Generic NameStimulator, Electrical, Implanted, For Parkinsonian Symptoms
ApplicantBoston Scientific Corp.
Date Received2020-02-20
Decision Date2020-03-17
PMAP150031
SupplementS029
Product CodeNHL 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 25155 Rye Canyon Loop valencia, CA 91355

Supplemental Filings

Supplement NumberDateSupplement Type
P150031Original Filing
S029 2020-02-20 30-day Notice
S028
S027 2019-11-06 30-day Notice
S026
S025
S024 2019-08-26 30-day Notice
S023 2019-08-16 30-day Notice
S022 2019-08-05 Special (immediate Track)
S021
S020 2019-05-08 30-day Notice
S019 2019-04-03 30-day Notice
S018 2019-04-03 30-day Notice
S017 2019-03-12 30-day Notice
S016
S015 2019-02-19 30-day Notice
S014 2019-02-13 30-day Notice
S013 2019-02-12 30-day Notice
S012 2019-01-31 30-day Notice
S011
S010 2018-10-29 30-day Notice
S009
S008 2018-07-23 30-day Notice
S007 2018-07-11 30-day Notice
S006 2018-05-21 30-day Notice
S005 2018-02-22 Normal 180 Day Track
S004
S003 2018-01-17 Normal 180 Day Track No User Fee
S002 2017-12-22 Normal 180 Day Track
S001 2017-12-21 Normal 180 Day Track

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