Atlas FDA

Vercise Deep Brain Stimulation (DBS) Systems

FDA premarket approval P150031/S036 · decided 2020-08-12

Approval details

PMA number
P150031
Supplement
S036
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
Vercise Deep Brain Stimulation (DBS) Systems
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Applicant
Boston Scientific Corp
Date received
2020-07-13
Decision date
2020-08-12
Days to decision
30 days
Decision code
APPR
Product code
NHL
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Approval of Changes being Effected (CBE) for the enhancement and harmonization of the physician and patient labeling to include precaution statements regarding risks of loss of coordination during activities requiring coordination (e.g. swimming) and bathing in the labeling across the device type.

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510(k) clearances by this applicant

RecordFirmDate
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21