This page includes the latest FDA filings for Spectranetics Corp 9965 Federal Drivecolorado Springs Co 80921 Pma Numberp910001 Supplement Numbers117 Date Received09 23 2022 Decision Date10 21 2022 Product Code Lpc 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 |
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SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS117 Date Received09/23/2022 Decision Date10/21/2022 Product Code LPC Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No | ELCA Coronary Laser Catheters | 2022-10-21 |