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Biom’Up puts his product on the market

Biom’Up, specialist in surgical hemostasis, announces today that it has received FDA marketing approval for HEMOBLASTTM Bellows, its flagship product, 7 months ahead of schedule.


This pre-marketing approval (PMA), which allows a Class III medical device to be marketed in the United States, is the most stringent pathway to approval by FDA for devices. The PMA application is based on scientific and clinical data demonstrating that the device is safe and effective for patients and users under usage prerequisites.


Read the press release

 

 

 

 

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