The clearance includes its Lifepak 1000, refurbished Lifepak 20 defibrillator and monitor, Lifepak 20e defibrillator and monitor and the Lifepak 15 defibrillator and monitor, the Redmond, Wash.-based company said.
“Physio-Control is excited to have reached this major milestone with our complete portfolio of devices in both the professional and public safety markets. 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,” Stryker EMS & Physio-Control VP and GM Anne Mullally said in a press release.
In February, Physio-Control initiated a select recall of its Lifepak 20e defibrillators and monitors over issues with power failures, according to a recall notice posted this month.