Singapore HSA registration DE0507941
Boston Scientific Farapulse Pulsed Field Ablation System
Singapore·CLASS D·Boston Scientific Corporation·Registered March 24, 2023Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0507941
- Registration Date
- March 24, 2023
- Change Notification Approval Date
- April 09, 2025
- Retention Due Date
- March 23, 2026
Product description
The FARAPULSE Pulsed Field Ablation (PFA) System is intended for the isolation of the pulmonary veins in the treatment of paroxysmal atrial fibrillation by rendering targeted cardiac tissue electrically non-conductive to prevent cardiac arrhythmia initiation or maintenance.
Product Owner
- Short Name
- Boston Scientific Corporation
- Address
- 300 Boston Scientific Way, Marlborough, MA 01752, UNITED STATES
Registrant
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model information
- Model Name(s)
- FARASTAR Catheter Connection Cable FARASTAR Catheter Connection Cable FARASTAR Gen 2 Catheter Connection Cable FARASTAR Stimulation Module Cable FARASTAR EGM Cable FARASTAR Stimulation Male Cable FARASTAR Stimulation Female Cable FARASTAR Stimulation Y-Cable, Long FARASTAR Stimulation Y-Cable, Short FARASTAR Record System Cath Pin Cable FARASTAR Recording System Module ECG Trunk Cable - AAMI FARASTAR Recording System Module ECG Output Module AAMI FARASTAR Record System EGM Input Module FARASTAR Snap Cable R/L - AAMI FARASTAR Snap Cable V Set - AAMI FARASTAR Snap Cable R/L - IEC FARASTAR Snap Cable C Set - IEC FARASTAR Recording System Module ECG Trunk Cable - IEC FFARASTAR Recording System Module ECG Output Module - IEC FARADRIVE Steerable Sheath Clear FARAWAVE Pulsed Field Ablation Catheter, 31mm FARAWAVE Pulsed Field Ablation Catheter, 35mm FARASTAR Pulsed Field Ablation Generator and Components FARASTAR Record System Module and Components FARASTAR Record System ECG Trunk Cable FARASTAR Record System ECG Output Module FARASTAR Pulsed Field Ablation Generator FARASTAR Pulsed Field Ablation Generator FARASTAR Record System Module FARASTAR Recording System Module
- Model Identifier(s)
- M004PF41M424 M004PF41M434 M004PF41M444 M004PF61M404 M004PF61M405 M004PF61M409 M004PF61M410 M004PF61M411 M004PF61M412 M004PF61M413 M004PF61M415 M004PF61M416 M004PF61M417 M004PF61M418 M004PF61M419 M004PF61M420 M004PF61M421 M004PF61M425 M004PF61M426 M004PFCE21M402 M004PFCE41M401 M004PFCE41M402 M004PFCE61M401 M004PFCE61M407 M004PFCE61M415 M004PFCE61M416 M004PFCE61M450 M004PFCE61M450R M004PFCE61M550 M004PFCE61M550R
About this record
Access comprehensive regulatory information for Boston Scientific Farapulse Pulsed Field Ablation System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507941 and owned by Boston Scientific Corporation. The device was registered on March 24, 2023.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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