Ophtec Usa Inc 6421 Congress Ave Suite 112boca Raton Fl 33487 Pma Numberp030023 Supplement Numbers008 Date Received02 08 2022 Decision Date07 21 2022 Product Code Mrj Advisory Committee Ophthalmic Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Ophtec Usa Inc 6421 Congress Ave Suite 112boca Raton Fl 33487 Pma Numberp030023 Supplement Numbers008 Date Received02 08 2022 Decision Date07 21 2022 Product Code Mrj Advisory Committee Ophthalmic Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
OPHTEC USA, INC.6421 Congress Ave., Suite 112boca Raton, FL 33487 PMA NumberP030023 Supplement NumberS008 Date Received02/08/2022 Decision Date07/21/2022 Product Code MRJ  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
RingJect and Capsular Tension Ring (CTR)2022-07-21

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