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Posted On: 10/16/2024 1:38:09 PM
Post# of 587
FDA Response Letters determine.....Approval or Denial!
https://www.biospace.com/complete-response-letters
"The FDA's Premarket Approval (PMA) process for medical devices is notably rigorous and time-consuming due to its thorough evaluation of high-risk devices. Typically, the PMA process can take 180 days and several years, with an average timeframe of 180 to 290 days from submitting a complete application to a decision." Hope and silence can be golden? FDA is fully aware of the Hemostyp
gauze product! Apparently the zoom meeting requested by UEEC is not necessary?
Our PMA 185 day period is quickly approaching.
Silence is golden!
$5-$10+
https://www.biospace.com/complete-response-letters
"The FDA's Premarket Approval (PMA) process for medical devices is notably rigorous and time-consuming due to its thorough evaluation of high-risk devices. Typically, the PMA process can take 180 days and several years, with an average timeframe of 180 to 290 days from submitting a complete application to a decision." Hope and silence can be golden? FDA is fully aware of the Hemostyp
gauze product! Apparently the zoom meeting requested by UEEC is not necessary?
Our PMA 185 day period is quickly approaching.
Silence is golden!
$5-$10+
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