HSA · registration DE0507941Boston Scientific Farapulse Pulsed Field Ablation System
SingaporeCardiovascularClass DBoston Scientific Corporation
Official record identity
- Registration number
- DE0507941
- Model name
- 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
- 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
- Registration date
- March 24, 2023
- Source update date
- April 09, 2025
Classification
- Risk class
- Class D
Official value: CLASS D
Published parties
- Product owner
- Boston Scientific Corporation
- Registrant / registration holder
- BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Official 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.
Additional source fields
- Product owner address
- 300 Boston Scientific Way, Marlborough, MA 01752, UNITED STATES
- Registrant address
- 9 NORTH BUONA VISTA DRIVE, #20-01, THE METROPOLIS, Singapore 138588
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.