Biotronik Inc 6024 Jean Roadlake Oswego Or 97035 Pma Numberp070008 Supplement Numbers143 Date Received11 15 2022 Decision Date01 12 2023 Product Code Nke Advisory Committee Cardiovascular Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Biotronik Inc 6024 Jean Roadlake Oswego Or 97035 Pma Numberp070008 Supplement Numbers143 Date Received11 15 2022 Decision Date01 12 2023 Product Code Nke Advisory Committee Cardiovascular Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material 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 P070008S143 BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS143 Date Received11/15/2022 Decision Date01/12/2023 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U	2023-01-12