Integra Lifesciences

FDA Filings

This page includes the latest FDA filings for Integra Lifesciences. 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 K120600 INTEGRA LIFESCIENCES	DURAGEN SECURE DURAL REGNERATION MATRIX	2012-06-15
PMN K103742 INTEGRA LIFESCIENCES	ACCELL EVO3 (FORMERLY ACCELL A2I)	2011-03-17

Similar & Related FDA Registered Companies

INTEGRA LIFESCIENCES CORPORATION
Integra LifeSciences Production Corporation
Integra LifeSciences Corporation (Owner Of TEI Biosciences)
INTEGRA SPINE (INTEGRA LIFESCIENCES)
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
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Integra LifeSciences Switzerland Sàrl

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202007049042	Stadersand,Federal Republic of Germany -> Oakland, California	CUSA CLARITY CART HS-CODE 94029000 FREIGHT PREPAID EXPRESS BL	20 PCS
2020061111473	Stadersand,Federal Republic of Germany -> Oakland, California	CUSA CLARITY CART HS-CODE 94029000	30 PCS
2020051110095	Stadersand,Federal Republic of Germany -> Oakland, California	CUSA CLARITY CART HS-CODE 94029000 FREIGHT PREPAID	20 PCS
2019091317645	Stadersand,Federal Republic of Germany -> Oakland, California	AUDITED CUSA CLARITY CART HS-CODE: 94029000 FREIGHT PREPAID GENERAL CMA CGM TERMS AND CONDITIONS TO BE FO UNDER WWW.CMA-CGM.COM	41 PCS