Biotronik Inc 6024 Jean Roadlake Oswego Or 97035 Pma Numberp070008 Supplement Numbers138 Date Received08 03 2022 Decision Date08 22 2022 Product Code Nke 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 Numberp070008 Supplement Numbers138 Date Received08 03 2022 Decision Date08 22 2022 Product Code Nke 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 P070008S138 BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS138 Date Received08/03/2022 Decision Date08/22/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico	2022-08-22