Market Overview

Physio-Control Receives Premarket Approval From the FDA On Its Full Portfolio of LIFEPAK® Professional Devices


(Product Bulletin) Physio-Control, now part of Stryker, today announced
it has received premarket approval (PMA) by the U.S. Food and Drug
Administration (FDA) to continue to market and distribute its full line
of LIFEPAK professional defibrillators in the U.S.

The list of professional-use defibrillators that received PMA approval
include: LIFEPAK 1000 defibrillator, LIFEPAK 20 (Refurbished)
defibrillator/monitor, LIFEPAK 20e defibrillator/monitor and LIFEPAK 15

"Physio-Control is excited to have reached this major milestone with our
complete portfolio of devices in both the professional and public safety
markets," says Anne Mullally, Vice President and GM, Stryker EMS and
Physio-Control. "This is the culmination of several years of significant
work, substantiating the safety and effectiveness of our devices, and is
the highest bar FDA Class III medical devices must meet. This represents
our continued commitment to producing the most reliable, highest
quality, and science-driven products that our customers need to support
their patients and communities."

In January 12, 2017 following an extensive submission, Physio-Control's
HeartSine® business group based in Belfast, Ireland, was the
first AED manufacturer to receive PMA for the three HeartSine samaritan®
models SAM 350P, SAM 360P and SAM 450P automated external
defibrillators (AEDs) as well as the Pad-Pak™, Pediatric-Pak™,
TSO-certified Pad-Pak and Saver EVO™ software. Physio-Control's AEDs,
December 21, 2017.

About Physio-Control, now part of Stryker

Physio-Control, now part of Stryker, is the world's leading provider of
professional emergency medical response solutions that predict or
intervene in life-threatening emergencies. The company's products
include LIFEPAK® monitor/defibrillators and automated
external defibrillators, LUCAS® Chest Compression Systems,
the LIFENET® System, HeartSine® AEDs and more.
Learn more at,
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About Stryker

Stryker is one of the world's leading medical technology companies and,
together with its customers, is driven to make healthcare better. The
company offers innovative products and services in Orthopaedics, Medical
and Surgical, and Neurotechnology and Spine that help improve patient
and hospital outcomes. More information is available at

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