Spectranetics Corp 9965 Federal Drivecolorado Springs Co 80921 Pma Numberp910001 Supplement Numbers114 Date Received02 14 2022 Decision Date02 24 2022 Product Code Lpc Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Spectranetics Corp 9965 Federal Drivecolorado Springs Co 80921 Pma Numberp910001 Supplement Numbers114 Date Received02 14 2022 Decision Date02 24 2022 Product Code Lpc Advisory Committee Cardiovascular Supplement Typespecial Immediate Track 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 Registration(s)

FDA Filings

Device
Company
DeviceDate
SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS114 Date Received02/14/2022 Decision Date02/24/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
ELCA Coronary Atherectomy Catheters2022-02-24

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