Biom Up S A S

FDA Filings

This page includes the latest FDA filings for Biom Up S A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K103081 BIOM'UP SAS	COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE	2012-03-02
PMN K103087 BIOM'UP SAS	COVAMAX RESORBABLE COLLAGEN MEMBRANE	2011-08-26

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• Biom'up France SAS
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• BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS102 Date Received06/14/2022 Decision Date07/14/2022 Product Code NRA  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• BIOMIMETIC THERAPEUTICS,LLC389 Nichol Mill Lnfranklin, TN 37067 PMA NumberP100006 Supplement NumberS013 Date Received12/15/2021 Decision Date06/13/2022 Product Code NOX  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• Biom'Up France SAS8 Allee Irene Joliot Curiesaint-priest 69800 PMA NumberP170012 Supplement NumberS028 Date Received11/23/2021 Decision Date04/22/2022 Product Code PMX  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS101 Date Received03/11/2022 Decision Date04/04/2022 Product Code NRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No