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Wednesday, April 10, 2024 12:34:04 PM
UHP press release clearly states this Is a full PMA and went so far as to provide the FDA link to the PMA process. Literally inviting readers to follow along with the timeline. There is no confusion here at all. Yet, you did your “research” on the 510k.
How desperate are you? The sad thing is no one else here would notice.
But you must have realized I would expose you.
Here’s the Company quote:
The company confirms that it has submitted via the FDA eSTAR portal its Premarket Approval (PMA) application for its absorbable hemostatic gauze, which will now be reviewed by the FDA and Health Canada. Information on the FDA review process for PMA applications can be found on the FDA website at:
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process.
…..please don’t try to explain that the two are interchangeable and Hemostyp was fast tracked into the 510k process .
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