Integra

FDA Filings

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

Integra holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• PRODUITS DENTAIRES SA

FDA Owner/Operator Registration

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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
• INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP810006 Supplement NumberS101 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
• 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
• INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP080013 Supplement NumberS024 Date Received09/07/2022 Decision Date10/07/2022 Product Code NQR  Advisory Committee Neurology 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 NumberP040034 Supplement NumberS035 Date Received09/07/2022 Decision Date10/07/2022 Product Code NQR  Advisory Committee Neurology 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
• 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 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
• 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
• 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
• 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.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 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
• 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
• INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP810006 Supplement NumberS098 Date Received04/04/2022 Decision Date04/28/2022 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 NumberS101 Date Received04/04/2022 Decision Date04/28/2022 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 NumberS100 Date Received03/21/2022 Decision Date04/20/2022 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 (IRELAND) LIMITED
• Integra LifeSciences Switzerland Sàrl
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• INTEGRA PAIN MANAGEMENT
• INTEGRA YORK PA, INC.
• INTEGRATED DENTAL SYSTEMS, LLC
• Integrated Medcraft LLC

Related Finance Registrations

NCAGE Code	F5832	INTEGRA
NCAGE Code	A0U5S	INTEGRA
CAGE Code	A0U5S	INTEGRA
CAGE Code	F5832	INTEGRA
DUNS	129035700	Integra