Vercise Genus™ Deep Brain Stimulation (DBS) System

FDA Premarket Approval P150031 S046

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 to use vlsip technologies as an alternate supplier for the ball grid array (bga), an electronic component on the printed circuit board assembly (pcba) of the implantable pulse generators (ipg) and external trial stimulators (ets) of the wavewriter alpha spinal cord stimulator (scs) system and vercise genus deep brain stimulation (dbs) system.

DeviceVercise Genus™ Deep Brain Stimulation (DBS) System
Generic NameStimulator, Electrical, Implanted, For Parkinsonian Symptoms
ApplicantBoston Scientific Corp.
Date Received2021-10-12
Decision Date2021-11-10
PMAP150031
SupplementS046
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
S046 2021-10-12 30-day Notice
S045
S044 2021-09-13 30-day Notice
S043 2021-05-24 30-day Notice
S042 2021-05-07 30-day Notice
S041 2021-04-19 30-day Notice
S040
S039
S038 2020-07-23 30-day Notice
S037 2020-07-13 30-day Notice
S036 2020-07-13 Special (immediate Track)
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
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