Asahi Kasei Medical Co L T D 1 105 Kanda Jinbochochiyoda Kutokyo 101 8 8101 Pma Numberp820033 Supplement Numbers016 Date Received12 09 2022 Decision Date01 05 2023 Product Code Mdp 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 Asahi Kasei Medical Co L T D 1 105 Kanda Jinbochochiyoda Kutokyo 101 8 8101 Pma Numberp820033 Supplement Numbers016 Date Received12 09 2022 Decision Date01 05 2023 Product Code Mdp 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 P820033S016 Asahi Kasei Medical Co., Ltd.1-105 Kanda Jinbochochiyoda-kutokyo 101-8-8101 PMA NumberP820033 Supplement NumberS016 Date Received12/09/2022 Decision Date01/05/2023 Product Code MDP  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Plasmaflo OP-05W(A)	2023-01-05