Atlas FDA

Vercise Deep Brain Stimulation (DBS) Systems

FDA premarket approval P150031/S090 · decided 2025-12-17

Approval details

PMA number
P150031
Supplement
S090
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Vercise Deep Brain Stimulation (DBS) Systems
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Applicant
Boston Scientific Corp
Date received
2025-11-20
Decision date
2025-12-17
Days to decision
27 days
Decision code
OK30
Product code
NHL
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
to implement the utilization of an alternate Laser Excise System for the Printed Circuit Board Assemblies used in the Wavewriter Alpha and Vercise Genus Rechargeable Implantable Pulse Generators

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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