This page includes the latest FDA filings for Cardiofocus Inc 500 Nickerson Roadmarlborough Ma 01752 Pma Numberp150026 Supplement Numbers013 Date Received03 04 2022 Decision Date04 02 2022 Product Code Oae Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Location 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 |
|---|---|---|
| CARDIOFOCUS, INC.500 Nickerson Roadmarlborough, MA 01752 PMA NumberP150026 Supplement NumberS013 Date Received03/04/2022 Decision Date04/02/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No | HeartLight® X3 Catheter with Excalibur Balloon™ | 2022-04-02 |