PMA P920047S133

Device: INTELLAGEN™ Cardiac Ablation System
Applicant: Boston Scientific Corp
PMA number: P920047
Supplement: S133
Product code: LPB
Decision date: 2024-07-17
Classification: Cardiovascular
Generic name: Cardiac ablation percutaneous catheter
Approval order 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)

Current openFDA PMA Record#

Device: INTELLAGEN™ Cardiac Ablation System
Applicant: Boston Scientific Corp
PMA number: P920047
Supplement: S133
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2024-07-17
Decision code: APPR
Date received: 2023-07-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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)