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

FDA Premarket Approval P150031 S030

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

Addition of an additional ethylene oxide (eo) sterilization chamber and associated sterilization process located at boston scientific dorado manufacturing site (bsc-dor)

DeviceVercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai
Generic NameStimulator, Electrical, Implanted, For Parkinsonian Symptoms
ApplicantBoston Scientific Corp.
Date Received2020-03-27
Decision Date2020-04-24
PMAP150031
SupplementS030
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
S035 2020-05-22 30-day Notice
S034
S033 2020-04-20 30-day Notice
S032 2020-04-17 30-day Notice
S031
S030 2020-03-27 30-day Notice
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

NIH GUDID Devices

Device IDPMASupp
08714729992158 P150031 026

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