(Total Views: 238)
Posted On: 06/25/2023 11:31:54 AM
Post# of 584
Reasonable doubt? Not IMO! The recent pr of 6/7 provides information that UEEC is submitting the revised PMA to be in accordance with Device III FDA proof of efficacy specifically sterilization and acceptable ph level.
"UHP has produced additional batches of its HemoStyp hemostatic gauze to demonstrate consistency and uniformity of its manufacturing process as required for Class III medical devices. Testing of these additional batches has produced satisfactory results which have been incorporated into the company’s PMA application file."The additional assurance the pr mentions is to presume FDA could question other areas for approval. "Concurrently with this effort, packaged product testing in collaboration with the company’s U.S. based, FDA certified packaging partner is being conducted to confirm packaging integrity, effective sterilization and other criteria for Class III products. This testing process is advancing as expected and the company anticipates its completion during the month of June as previously stated."
Could be an interesting week ahead.
$5-$10+
"UHP has produced additional batches of its HemoStyp hemostatic gauze to demonstrate consistency and uniformity of its manufacturing process as required for Class III medical devices. Testing of these additional batches has produced satisfactory results which have been incorporated into the company’s PMA application file."The additional assurance the pr mentions is to presume FDA could question other areas for approval. "Concurrently with this effort, packaged product testing in collaboration with the company’s U.S. based, FDA certified packaging partner is being conducted to confirm packaging integrity, effective sterilization and other criteria for Class III products. This testing process is advancing as expected and the company anticipates its completion during the month of June as previously stated."
Could be an interesting week ahead.
$5-$10+
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