Biotronik Inc6024 Jean Roadlake Oswego Or 97035 Pma Numberp170030 Supplement Numbers021 Date Received01 31 2022 Decision Date02 23 2022 Product Code Niq Advisory Committee Cardiovascular 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 Biotronik Inc6024 Jean Roadlake Oswego Or 97035 Pma Numberp170030 Supplement Numbers021 Date Received01 31 2022 Decision Date02 23 2022 Product Code Niq Advisory Committee Cardiovascular 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 P170030S021 Biotronik, Inc6024 Jean Roadlake Oswego, OR 97035 PMA NumberP170030 Supplement NumberS021 Date Received01/31/2022 Decision Date02/23/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	ORSIRO Sirolimus Eluting Coronary Stent System and Orsiro Mission Sirolimus Eluting Coronary Stent System	2022-02-23