Atlas FDA

INTELLAGEN™ Cardiac Ablation System

FDA premarket approval P150005/S079 · decided 2024-07-17

Approval details

PMA number
P150005
Supplement
S079
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
INTELLAGEN™ Cardiac Ablation System
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
Boston Scientific Corp
Date received
2023-07-14
Decision date
2024-07-17
Days to decision
369 days
Decision code
APPR
Product code
OAD
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
an alternate and compatible radiofrequency (RF) generator, remote control, irrigation pump, tubing set, and foot pedal referred to collectively as the INTELLAGEN™ Cardiac Ablation System (INTELLAGEN)

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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