I E M G M B H

FDA Filings

This page includes the latest FDA filings for I E M G M B H. 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 K153557 I.E.M. GMBH	ABPM 7100, Hypertension Management Software	2016-07-19
PMN K140928 I.E.M. GMBH	ABPM7100	2014-09-15
PMN K110603 I.E.M. GMBH	HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)	2011-12-16
PMN K072446 I.E.M. GMBH	MOBIL-O-GRAPH NG 24 H ABP-CONTROL	2007-11-29
PMN K041313 I.E.M. GMBH	STABIL-O-GRAPH	2004-06-18

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• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS093 Date Received11/18/2022 Decision Date12/16/2022 Product Code MNQ  Advisory Committee Anesthesiology Clinical TrialsNCT04457154 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Integra LifeSciences Corp.105 Morgan Ln.plainsboro, NJ 08536 PMA NumberP900033 Supplement NumberS103 Date Received11/14/2022 Decision Date12/07/2022 Product Code MGR  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS088 Date Received07/29/2022 Decision Date08/19/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Integra LifeSciences Corp.105 Morgan Ln.plainsboro, NJ 08536 PMA NumberP900033 Supplement NumberS102 Date Received06/07/2022 Decision Date07/01/2022 Product Code MGR  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS081 Date Received05/27/2022 Decision Date06/22/2022 Product Code LKK  Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS084 Date Received05/20/2022 Decision Date06/16/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Integra LifeSciences Corp.105 Morgan Ln.plainsboro, NJ 08536 PMA NumberP900033 Supplement NumberS100 Date Received04/20/2022 Decision Date05/20/2022 Product Code MGR  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Integra LifeSciences Corp.105 Morgan Ln.plainsboro, NJ 08536 PMA NumberP900033 Supplement NumberS099 Date Received04/04/2022 Decision Date05/05/2022 Product Code MGR  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS083 Date Received03/15/2022 Decision Date04/07/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS082 Date Received03/02/2022 Decision Date04/01/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS080 Date Received02/17/2022 Decision Date03/16/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS081 Date Received02/17/2022 Decision Date03/14/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS079 Date Received02/11/2022 Decision Date03/10/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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Related Finance Registrations

NCAGE Code	CD243	I.E.M. GMBH
NCAGE Code	CC811	I.E.M. GMBH
CAGE Code	CD243	I.E.M. GMBH
CAGE Code	CC811	I.E.M. GMBH