I M T

FDA Filings

This page includes the latest FDA filings for I M T. 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
GUDID 03760264690115 I M T	M'Ath PACS	2019-10-02
GUDID 03760264690061 I M T	M'Ath	2019-10-02

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• INTERSECT ENT1555 Adams Drmenlo Park, CA 94025 PMA NumberP100044 Supplement NumberS051 Date Received11/25/2022 Decision Date12/22/2022 Product Code OWO  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS104 Date Received11/21/2022 Decision Date12/19/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• IRVINE BIOMEDICAL,INC.(IBI)2375 Morse Ave.irvine, CA 92614 PMA NumberP040042 Supplement NumberS054 Date Received11/14/2022 Decision Date12/08/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• IRVINE BIOMEDICAL,INC.(IBI)2375 Morse Ave.irvine, CA 92614 PMA NumberP040042 Supplement NumberS052 Date Received10/19/2022 Decision Date11/15/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS083 Date Received08/30/2022 Decision Date09/29/2022 Product Code LKK  Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Illumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS023 Date Received08/18/2022 Decision Date08/30/2022 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Impulse Dynamics (USA), Inc.30 Ramland Road South, Suite 204orangeburg, NY 10962 PMA NumberP180036 Supplement NumberS015 Date Received07/22/2022 Decision Date08/18/2022 Product Code QFV  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP810006 Supplement NumberS100 Date Received06/06/2022 Decision Date07/06/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS103 Date Received06/06/2022 Decision Date07/06/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INTEGRA LIFESCIENCES CORP.311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP840062 Supplement NumberS086 Date Received06/06/2022 Decision Date07/06/2022 Product Code LPG  Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Illumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS022 Date Received06/13/2022 Decision Date07/05/2022 Product Code PQP  Advisory Committee Pathology 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
• INTERSECT ENT1555 Adams Drmenlo Park, CA 94025 PMA NumberP100044 Supplement NumberS049 Date Received03/28/2022 Decision Date06/24/2022 Product Code OWO  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process 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
• InSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS021 Date Received03/10/2022 Decision Date06/07/2022 Product Code POH  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• INTEGRA LIFESCIENCES CORP.311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP840062 Supplement NumberS085 Date Received04/20/2022 Decision Date05/20/2022 Product Code LPG  Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP810006 Supplement NumberS099 Date Received04/20/2022 Decision Date05/20/2022 Product Code LMF  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 NumberS080 Date Received04/26/2022 Decision Date05/20/2022 Product Code LKK  Advisory Committee General Hospital 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 CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS102 Date Received04/20/2022 Decision Date05/20/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• INTEGRA LIFESCIENCES CORP.311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP840062 Supplement NumberS084 Date Received04/04/2022 Decision Date04/28/2022 Product Code LPG  Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• 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
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