Biom Up S A

FDA Filings

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

FDA Registration(s)

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMA P170012S020 Biom'Up SA	HEMOBLAST Bellows	2019-11-07
PMA P170012S019 Biom'Up SA	HEMOBLAST Bellows	2019-09-12
PMA P170012S018 Biom'Up SA	HEMOBLAST™ Bellows	2019-06-15
PMA P170012S017 Biom'Up SA	Hemoblast Bellows	2019-05-21
PMA P170012S016 Biom'Up SA	HEMOBLAST Bellows	2019-05-15
PMA P170012S015 Biom'Up SA	HEMOBLAST Bellows	2019-03-13
PMA P170012S014 Biom'Up SA	HEMOBLAST™ Bellows	2019-03-05
PMA P170012S007 Biom'Up SA	HEMOBLAST™ Bellows Laparoscopic Applicator	2019-01-18
PMA P170012S013 Biom'Up SA	HEMOBLAST™ Bellows	2019-01-11
PMA P170012S012 Biom'Up SA	HEMOBLAST™ Bellows	2018-11-29
PMA P170012S009 Biom'Up SA	HEMOBLAST Bellows	2018-11-16
PMA P170012S011 Biom'Up SA	HEMOBLAST™ Bellows	2018-10-10
PMA P170012S010 Biom'Up SA	HEMOBLAST™ Bellows	2018-09-26
PMA P170012S008 Biom'Up SA	HEMOBLAST™ Bellows	2018-08-08
PMA P170012S006 Biom'Up SA	HEMOBLAST™ Bellows	2018-07-16
PMA P170012S005 Biom'Up SA	HEMOBLAST™ Bellows	2018-07-11
PMA P170012S004 Biom'Up SA	HEMOBLAST™ Bellows	2018-06-14
PMA P170012S003 Biom'Up SA	HEMOBLAST™ Bellows	2018-05-10
PMA P170012S001 Biom'Up SA	HEMOBLAST™ Bellows	2018-05-02
PMA P170012S002 Biom'Up SA	Hemoblast Bellows	2018-04-10
PMA P170012 Biom'Up SA	HEMOBLAST™ Bellows	2017-12-15

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BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS103 Date Received09/29/2022 Decision Date10/25/2022 Product Code NRA Advisory Committee Orthopedic Supplement Type30-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 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

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