This page includes the latest FDA filings for Biotronik Inc 6024 Jean Roadlake Oswego Or 97035 Pma Numberp070008 Supplement Numbers139 Date Received08 29 2022 Decision Date09 15 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.
Device Company | Device | Date |
|---|---|---|
| BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS139 Date Received08/29/2022 Decision Date09/15/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) | 2022-09-15 |