Approx 1 month has passed since the 8/19 pr updati
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Posted On: 09/12/2024 8:32:35 AM
Approx 1 month has passed since the 8/19 pr updating the FDA progress?
Please send UEEC and Brian Thom a message requesting an update?
info@uhpcorp.com
"Following the company's March 21 submission of its PMA application and the FDA's June 18 "Deficiencies Letter" to the company listing certain questions and comments on various elements of the application, on August 15, UHP submitted a Submission Issue Request to the FDA responding to certain questions and detailing its approach to addressing certain identified deficiencies."
"The company has requested video conference with the FDA PMA application review team to discuss its responses and proposed solutions to the deficiencies. UHP anticipates the meeting to take place in early September."
UHP's Chief Executive, Brian Thom, commented: "We look forward to an interactive engagement with the FDA to gain clarity on what actions and information are needed in order to make a final determination on the merits of our PMA application." Reassuring?
$5-$10+
Please send UEEC and Brian Thom a message requesting an update?
info@uhpcorp.com
"Following the company's March 21 submission of its PMA application and the FDA's June 18 "Deficiencies Letter" to the company listing certain questions and comments on various elements of the application, on August 15, UHP submitted a Submission Issue Request to the FDA responding to certain questions and detailing its approach to addressing certain identified deficiencies."
"The company has requested video conference with the FDA PMA application review team to discuss its responses and proposed solutions to the deficiencies. UHP anticipates the meeting to take place in early September."
UHP's Chief Executive, Brian Thom, commented: "We look forward to an interactive engagement with the FDA to gain clarity on what actions and information are needed in order to make a final determination on the merits of our PMA application." Reassuring?
$5-$10+
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