MAKE WAY FOR THE FIRST ACTIVE HEMOSTATIC POWDER

MAKE WAY FOR THE FIRST ACTIVE HEMOSTATIC POWDER

27 OCTOBER 2017

Biom’up provides regulatory update regarding HEMOBLAST™ Bellows 

Saint-Priest, France, October 27, 2017 – Biom’Up, specialist of surgical hemostasis, today provides a regulatory update regarding the United States Food and Drug Administration’s (FDA) review of the company’s Premarket Approval (PMA) application for its HEMOBLASTTM Bellows.

The FDA conducted a PMA pre-approval inspection at the Biom’up Saint Priest, France, manufacturing facility. The four-day Premarket Approval inspection focused on the firm’s HEMOBLASTTM Bellows product line and did not result in any FDA-483, Inspectional Observations.
This inspection was part of the medical device approval process to market HEMOBLASTTM Bellows within the United States of America. Following the inspection, the FDA will provide the company with an inspection report and continue its review of the PMA.

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pr-27-10-17

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Rechtliche Informationen: HEMOBLAST™ Bellows - Implantierbares Medizinprodukt der Klasse III für die Chirurgie, nur für den Gebrauch durch qualifizierte medizinische Fachkräfte vorgesehen, Erstattung abhängig vom jeweiligen Land.
Vor Gebrauch die Anweisungen auf der Verpackung sorgfältig durchlesen. CE0086: BSI - Hersteller: Biom’up SA Frankreich.