Biotronik Inc 6024 Jean Roadlake Oswego Or 97035 Pma Numberp160025 Supplement Numbers014 Date Received04 20 2022 Decision Date05 20 2022 Product Code Nip 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 Inc 6024 Jean Roadlake Oswego Or 97035 Pma Numberp160025 Supplement Numbers014 Date Received04 20 2022 Decision Date05 20 2022 Product Code Nip 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 P160025S014 BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS014 Date Received04/20/2022 Decision Date05/20/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Pulsar-18 Stent Systems	2022-05-20