Merz North America Inc4133 Courtney Roadsuite 10franksville Wi 53126 Pma Numberp050052 Supplement Numbers135 Date Received04 08 2022 Decision Date05 05 2022 Product Code Lmh Advisory Committee General Plastic Surgery 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 Merz North America Inc4133 Courtney Roadsuite 10franksville Wi 53126 Pma Numberp050052 Supplement Numbers135 Date Received04 08 2022 Decision Date05 05 2022 Product Code Lmh Advisory Committee General Plastic Surgery 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 Filings

Device Company	Device	Date
PMA P050052S135 MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050052 Supplement NumberS135 Date Received04/08/2022 Decision Date05/05/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	RADIESSE® Injectable Implant, including RADIESSE® Hands, RADIESSE® (+) Lidocaine, and RADIESSE® (+) Jawline	2022-05-05