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Sign in to claim this brandFarapulse 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
- Website
- BostonScientific.com
- facebook.com/BostonScientific
- [email protected]
- Phone
- +1 763-213-2406
- PRRC Contact
- Nicole Ledder
- EUDAMED SRN
- US-MF-000017969
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Faradrive™ | 21M402 | EUDAMED | Class III | Active |
| Farastar™ | M004PFCE61M400 | EUDAMED | Class IIb | Active |
| Farastar™ | 61M410 | EUDAMED | Class IIb | Active |
| Farastar™ | 61M411 | EUDAMED | Class IIb | Active |
| Farastar | 61M407 | EUDAMED | Class IIb | Active |
| Farastar™ | 61M409 | EUDAMED | Class IIb | Active |
| Farastar | 41M404 | EUDAMED | Class III | Active |
| Farastar™ | 61M405 | EUDAMED | Class IIb | Active |
| Farastar | 61M401 | EUDAMED | Class IIb | Active |
| Farastar™ | 61M415 | EUDAMED | Class IIb | Active |
| Farawave™ | 41M401 | EUDAMED | Class III | Active |
| Farastar™ | 61M404 | EUDAMED | Class IIb | Active |
| FARAPULSE™ Pulsed Field Ablation System (FARAPULSE) | P230030 | FDA PMA | Class III | Active |
| Farastar™ | 61M417 | EUDAMED | Class IIb | Active |
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