Integra Life Sciences Corp

FDA Filings

This page includes the latest FDA filings for Integra Life Sciences Corp. 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 K132250 INTEGRA LIFE SCIENCES CORPORATION	INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM	2014-03-24
PMN K110528 INTEGRA LIFE SCIENCES CORPORATION	INTEGRA LED SURGICAL HEADLIGHT SYSTEM	2011-05-11

Similar & Related FDA Registered Companies

INTEGRA LIFESCIENCES CORPORATION
Integra LifeSciences Production Corporation
Integra LifeSciences Corporation (Owner Of TEI Biosciences)
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

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019092118510	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	DRYER	2 PKG