Cooper Vision Inc

FDA Filings

This page includes the latest FDA filings for Cooper Vision Inc. 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 K112302 COOPER VISION, INC.	PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES	2011-12-21
PMN K032873 COOPER VISION, INC.	PROCLEAR COMPATIBLES MULTIFOCAL	2003-11-07

Similar & Related FDA Registered Companies

COOPERVISION, INC.
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS153 Date Received12/21/2022 Decision Date01/19/2023 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS015 Date Received12/19/2022 Decision Date01/13/2023 Product Code QIT Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS013 Date Received12/14/2022 Decision Date01/12/2023 Product Code QIT Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS014 Date Received12/16/2022 Decision Date01/10/2023 Product Code QIT Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS152 Date Received11/29/2022 Decision Date12/21/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS151 Date Received11/09/2022 Decision Date12/07/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS012 Date Received09/30/2022 Decision Date12/07/2022 Product Code QIT Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS150 Date Received10/25/2022 Decision Date11/21/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS149 Date Received09/30/2022 Decision Date10/26/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS011 Date Received08/23/2022 Decision Date09/22/2022 Product Code QIT Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS010 Date Received08/17/2022 Decision Date09/15/2022 Product Code QIT Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS148 Date Received07/21/2022 Decision Date08/18/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS147 Date Received07/11/2022 Decision Date08/08/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS146 Date Received04/27/2022 Decision Date07/25/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP870024 Supplement NumberS062 Date Received04/15/2022 Decision Date05/10/2022 Product Code MWL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP050031 Supplement NumberS009 Date Received04/15/2022 Decision Date05/10/2022 Product Codes NUU MWL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS145 Date Received04/06/2022 Decision Date05/03/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS143 Date Received03/31/2022 Decision Date04/27/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CooperVision, Inc.6101 Bollinger Canyon Road, Suite 500san Ramon, CA 94583 PMA NumberP080011 Supplement NumberS140 Date Received03/17/2022 Decision Date04/14/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	1AA04	COOPER VISION INC
CAGE Code	1AA04	COOPER VISION INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020040733693	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	THERMAL TRANSFER RIBBON	1 PKG
2020040136232	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	THERMAL TRANSFER RIBBON	1 PKG
2020033150342	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	THERMAL TRANSFER RIBBON	1 PKG
2019040454000	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	THERMAL TRANSFER RIBBON	1 PKG
2019021950004	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	THERMAL TRANSFER RIBBON	1 PKG
2018111656821	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	THERMAL TRANSFER RIBBON	1 PKG
201809089513	Liverpool,United Kingdom -> New York, New York	THERMAL TRANSFER RIBBON	1 PKG
2018041648084	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	THERMAL TRANSFER RIBBON	1 PKG