L N K I N T

FDA Filings

This page includes the latest FDA filings for L N K I N 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
Xpect Cold Relief Cintas Corporation, L.N.K. International	Otc Medication	2024-12-26
Xpect Cold Relief Cintas Corporation, L.N.K. International	Otc Medication	2023-12-29
Xpect Cold Relief Cintas Corporation, L.N.K. International	Otc Medication	2023-01-01
Xpect Cold Relief Cintas Corporation, L.N.K. International	Otc Medication	2021-03-31

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• LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS038 Date Received08/05/2022 Decision Date02/01/2023 Product Code PQP  Advisory Committee Pathology Clinical TrialsNCT02609776 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
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• Lenstec, Inc.1765 Commerce Avenue Northst. Petersburg, FL 33716 PMA NumberP200020 Supplement NumberS002 Date Received10/20/2022 Decision Date11/17/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
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• Lenstec, Inc.1765 Commerce Avenue Northst. Petersburg, FL 33716 PMA NumberP200020 Supplement NumberS001 Date Received08/18/2022 Decision Date09/16/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS036 Date Received03/29/2022 Decision Date08/11/2022 Product Code PQP  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS035 Date Received03/08/2022 Decision Date08/11/2022 Product Code PQP  Advisory Committee Pathology Clinical TrialsNCT03505710 Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Lenstec, Inc.1765 Commerce Avenue Northst. Petersburg, FL 33716 PMA NumberP200020 Date Received03/16/2020 Decision Date07/22/2022 Product Code MFK  Advisory Committee Ophthalmic Clinical TrialsNCT02487160 Expedited Review Granted? No
• LivaNova USA, Inc.100 Cyberonics Blvd.houston, TX 77058 PMA NumberP970003 Supplement NumberS235 Date Received02/22/2022 Decision Date03/09/2022 Product Codes MUZ LYJ  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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