This page includes the latest FDA filings for Biotronik Inc 6024 Jean Roadlake Oswego Or 97035 Pma Numberp070008 Supplement Numbers136 Date Received02 07 2022 Decision Date04 11 2022 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.
Device Company | Device | Date |
|---|---|---|
| BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS136 Date Received02/07/2022 Decision Date04/11/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No | PSW 2201.U/1 and NEO 2201.U/1 | 2022-04-11 |