Philips

Philips

a global leader in health technology, today announced that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the company’s premarket approval (PMA) application for its HeartStart OnSite defibrillator [1] and HeartStart Home defibrillator [2], and the relevant supporting accessories, such as batteries and pad electrodes.

 

Philips’ HeartStart OnSite and HeartStart Home defibrillators are the only over-the-counter automated external defibrillators (AEDs) available to consumers in the US, while the HeartStart Home defibrillator is the only AED specifically indicated for home environments.

 

“We are committed to delivering high quality, innovative AEDs to provide personalized therapy to victims of sudden cardiac arrest,” said Arman Voskerchyan, Business Leader Therapeutic Care at Philips. “Premarket approval for our HeartStart OnSite and HeartStart Home defibrillators, currently the only over-the-counter AEDs available in the US, reflects the robust work of our teams that delivered the strong and extensive technical, clinical and production data included in the PMA filing for these devices.”

 

PMA for Philips’ HeartStart OnSite and HeartStart Home defibrillators can be found here. These devices already had FDA 510(k) clearance, but are now subject to PMA.

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    Original Price $1,549.00
    Current Price $1,280.00

    Philips - HeartStart OnSite AED with Slim Carrying Case

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    With access to the right equipment and support, everyone can help save a life. Philips HeartStart OnSite defibrillator with Life Guidance acts as y...

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    Original Price $1,549.00
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  • Philips - HeartStart OnSite AED with Standard Carrying Case
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    Original Price $1,630.00
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    Philips - HeartStart OnSite AED with Standard Carrying Case

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    With access to the right equipment and support, everyone can help save a life. Philips HeartStart OnSite defibrillator with Life Guidance acts as y...

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    Original Price $1,630.00
    Current Price $1,334.00
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  • Philips - HeartStart OnSite AED with Ready-Pack configuration, Standard Carrying Case
    Philips - HeartStart OnSite AED with Ready-Pack configuration, Standard Carrying Case
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    Original Price $1,630.00
    Current Price $1,369.00

    Philips - HeartStart OnSite AED with Ready-Pack configuration, Standard Carrying Case

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    Philips, the leader and innovator in portable AED technology designed the HeartStart OnSite Defibrillator to be the most user friendly and reliable...

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    Original Price $1,630.00
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  • Philips - HeartStart OnSite Defibrillator - English
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    Original Price $1,467.00
    Current Price $1,250.00

    Philips - HeartStart OnSite Defibrillator - English

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    Philips, the leader in portable defibrillation technology, designed the HeartStart OnSite Defibrillator for the ordinary person in the extraordinar...

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    Original Price $1,467.00
    Current Price $1,250.00
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  • Philips - Manual, Owner's - HeartStart Home - English
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    Original Price $22.00
    Current Price $12.00

    Philips - Manual, Owner's - HeartStart Home - English

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    Guide to Set Up, Operation, Maintenance, and Accessories. This is the original manual that you refer to for Setting Up, Operation, and Maintenance ...

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  • Philips - Manual, Instructions for Use - HeartStart Home - English
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    Original Price $40.00
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    Philips - Manual, Instructions for Use - HeartStart Home - English

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    The Quick Reference is a brief instruction guide for the defibrillator operator. Its short captions and straightforward drawings break down each st...

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  • Philips - Quick Reference Guide  - HS1 - English
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    Philips - Quick Reference Guide - HS1 - English

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  • Philips - Manual, Instructions for Use - HeartStart OnSite - French
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    Philips - Manual, Instructions for Use - HeartStart OnSite - French

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  • Philips - Manual, Instructions for Use - HeartStart OnSite - English
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    Original Price $40.00
    Current Price $24.00

    Philips - Manual, Instructions for Use - HeartStart OnSite - English

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    Philips Heartstart Onsite Defibrillator Owners Manual M5066-91900. Guide to Set Up, Operation, Maintenance, and Accessories. This is the original m...

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    Original Price $40.00
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  • Philips - DVD/CD - Instructor’s Tool Kit - English
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  • Philips - Manikin - External (metallic strips) Adapters (5)
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  • Philips - Replacement carrying case for HeartStart OnSite Trainer
    Philips - Replacement carrying case for HeartStart OnSite Trainer
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    Original Price $49.00
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  • Philips - Replacement Training Pads (1 pair) – no cartridge - Pediatric
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    Original Price $49.00
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    Philips - Replacement Training Pads (1 pair) – no cartridge - Pediatric

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    Original Price $49.00
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  • Philips - Training Pads cartridge (1 pair) - Pediatric
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    Original Price $98.00
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    Philips - Training Pads cartridge (1 pair) - Pediatric

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    Philips - Pads Placement Guide (Flat man) - Adult

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    Man Adult Pad Placement Guide that serves as a guide for electrode pad placement during a sudden cardiac arrest (SCA). Designed for training purposes.

    Original Price $49.00
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  • Philips - Replacement Training Pads (1 pair) - no cartridge - Adult
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    Original Price $41.00
    Current Price $27.00

    Philips - Replacement Training Pads (1 pair) - no cartridge - Adult

    Relaxacare

    These special purpose pads are installed in the HeartStart OnSite and the HeartStart Trainer. When installed in the OnSite, they suspend the defibr...

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    Original Price $41.00
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  • Philips - Training Pads cartridge (1 pair) - Adult
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    Adult size training pad cartridges for demonstrating emergency scenarios when used with heartstart Hs1 defibrillator Non-clinical pads, when insta...

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  • Philips - Instructions for use for HeartStart OnSite Trainer
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  • Philips - HeartStart OnSite Trainer - English
    Philips - HeartStart OnSite Trainer - English
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    Original Price $326.00
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    Philips - HeartStart OnSite Trainer - English

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    Empower your students by teaching them how to use the HeartStart OnSite Defibrillator to save lives. The HeartStart AED Trainer simulates how the H...

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  • Philips - Hard Case, Plastic Waterproof Shell
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    Original Price $229.00
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  • Philips - HeartStart OnSite Slim Carry Case
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    Original Price $139.00
    Current Price $117.00

    Philips - HeartStart OnSite Slim Carry Case

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    This slim carry case is constructed with semi-rigid materials and covered in durable red cordura. The case holds the HeartStart OnSite Defibrillato...

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    Original Price $139.00
    Current Price $117.00
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