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REDMOND, Wash.--(BUSINESS WIRE)--(Product Bulletin) Physio-Control announced today that the company’s HeartSine® samaritan® PAD 360P (SAM 360P) fully automatic external defibrillator (AED) is now available for sale in the United States, having received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA).
HeartSine, acquired by Physio-Control in 2015, is the first to receive approval for a new AED product under the FDA PMA regulatory process, which is the most stringent for medical devices in the United States and is a new FDA regulatory requirement for the AED industry.
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