On X Life Technologies Inc 1655 Roberts Blvd Nwkennesaw Ga 30144 Pma Numberp000037 Supplement Numbers060 Date Received07 15 2022 Decision Date08 01 2022 Product Code Lwq Advisory Committee Cardiovascular 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 On X Life Technologies Inc 1655 Roberts Blvd Nwkennesaw Ga 30144 Pma Numberp000037 Supplement Numbers060 Date Received07 15 2022 Decision Date08 01 2022 Product Code Lwq Advisory Committee Cardiovascular 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
On-X Life Technologies, Inc.1655 Roberts Blvd Nwkennesaw, GA 30144 PMA NumberP000037 Supplement NumberS060 Date Received07/15/2022 Decision Date08/01/2022 Product Code LWQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
 On- X Prosthetic Heart Valve, Ascending Aortic Prothesis2022-08-01

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