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Farapulse Inc

United States·US-MF-000017969

Last updated September 18, 2026

About

Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.

From the manufacturer's own website. Source

What Farapulse Inc makes

Farapulse Inc manufactures implantable cardiac devices, including pacemakers and implantable cardioverter-defibrillators (ICDs) under the FARADRIVE™ and FARASTAR™ brands. These devices are designed to manage arrhythmias by delivering pacing and shock therapies to restore normal heart rhythms. The company also produces external cardiac monitoring systems under the FARAWAVE™ brand, intended for real-time cardiac rhythm analysis and remote patient monitoring.

The company’s devices are classified as Class III and Class IIb under regulatory frameworks, with some products authorised via the FDA’s Premarket Approval (PMA) process and listed in the EU’s EUDAMED database. Farapulse Inc is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
United States
Address
3715 Haven Ave., Menlo Park, United States
Phone
+1 763-213-2406
PRRC Contact
Nicole Ledder
EUDAMED SRN
US-MF-000017969
FDA FEI Number
—
DUNS Number
—

Catalogue (14)

DeviceModel / ReferenceRegistriesClassStatus
Faradrive™ 21M402
EUDAMED
Class IIIActive
Farastar™ M004PFCE61M400
EUDAMED
Class IIbActive
Farastar™ 61M410
EUDAMED
Class IIbActive
Farastar™ 61M411
EUDAMED
Class IIbActive
Farastar 61M407
EUDAMED
Class IIbActive
Farastar™ 61M409
EUDAMED
Class IIbActive
Farastar 41M404
EUDAMED
Class IIIActive
Farastar™ 61M405
EUDAMED
Class IIbActive
Farastar 61M401
EUDAMED
Class IIbActive
Farastar™ 61M415
EUDAMED
Class IIbActive
Farawave™ 41M401
EUDAMED
Class IIIActive
Farastar™ 61M404
EUDAMED
Class IIbActive
FARAPULSE™ Pulsed Field Ablation System (FARAPULSE) P230030
FDA PMA
Class IIIActive
Farastar™ 61M417
EUDAMED
Class IIbActive

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