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

FDA premarket approval P150031/S041 · decided 2021-04-23

Approval details

PMA number
P150031
Supplement
S041
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Deep Brain Stimulation (DBS) Systems - Vercise PC, Gevia and Genus Systems
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Applicant
Boston Scientific Corp
Date received
2021-04-19
Decision date
2021-04-23
Days to decision
4 days
Decision code
OK30
Product code
NHL
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Addition of two new reflow ovens to the manufacturing process for the Printed Circuit Board Assemblies (PCBAs) of the Implantable Pulse Generator (IPG) and External Trial Stimulator (ETS).

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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