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Posted On: 11/04/2024 8:21:48 AM
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https://finance.yahoo.com/news/united-health-...00023.html
“While we are pleased to confirm the path to resolving the list of deficiencies in our PMA application, we are disappointed that the strong results of our pivotal study and low incidence of adverse events were not sufficient to address the FDA’s specific concern regarding organ space applications of our device. The company will devote its resources to completing these additional surgical procedures efficiently and is confident that the results will reinforce the results of the existing study.”
UHP’s Chief Executive, Brian Thom, commented: “While we are pleased to confirm the path to resolving the list of deficiencies in our PMA application, we are disappointed that the strong results of our pivotal study and low incidence of adverse events were not sufficient to address the FDA’s specific concern regarding organ space applications of our device. The company will devote its resources to completing these additional surgical procedures efficiently and is confident that the results will reinforce the results of the existing study.”
$5-$10++
https://finance.yahoo.com/news/united-health-...00023.html
“While we are pleased to confirm the path to resolving the list of deficiencies in our PMA application, we are disappointed that the strong results of our pivotal study and low incidence of adverse events were not sufficient to address the FDA’s specific concern regarding organ space applications of our device. The company will devote its resources to completing these additional surgical procedures efficiently and is confident that the results will reinforce the results of the existing study.”
UHP’s Chief Executive, Brian Thom, commented: “While we are pleased to confirm the path to resolving the list of deficiencies in our PMA application, we are disappointed that the strong results of our pivotal study and low incidence of adverse events were not sufficient to address the FDA’s specific concern regarding organ space applications of our device. The company will devote its resources to completing these additional surgical procedures efficiently and is confident that the results will reinforce the results of the existing study.”
$5-$10++
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