Biotronik Inc 6024 Jean Roadlake Oswego Or 97035 Pma Numberp950037 Supplement Numbers233 Date Received01 05 2022 Decision Date03 04 2022 Product Code Dxy Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Biotronik Inc 6024 Jean Roadlake Oswego Or 97035 Pma Numberp950037 Supplement Numbers233 Date Received01 05 2022 Decision Date03 04 2022 Product Code Dxy Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change Pas 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 P950037S233 BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS233 Date Received01/05/2022 Decision Date03/04/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No	Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60	2022-03-04