Kaneka Pharma America Corp 546 Fifth Ave 21st Floornew York Ny 10036 Pma Numberp910018 Supplement Numbers033 Date Received03 30 2022 Decision Date04 29 2022 Product Code Mmy Advisory Committee Gastroenterology Urology 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 Kaneka Pharma America Corp 546 Fifth Ave 21st Floornew York Ny 10036 Pma Numberp910018 Supplement Numbers033 Date Received03 30 2022 Decision Date04 29 2022 Product Code Mmy Advisory Committee Gastroenterology Urology 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 P910018S033 KANEKA PHARMA AMERICA CORP.546 Fifth Ave., 21st Floornew York, NY 10036 PMA NumberP910018 Supplement NumberS033 Date Received03/30/2022 Decision Date04/29/2022 Product Code MMY  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	LIPOSORBER LA-15 System	2022-04-29