Spectranetics Corp 9965 Federal Drivecolorado Springs Co 80921 Pma Numberp910001 Supplement Numbers116 Date Received06 17 2022 Decision Date08 19 2022 Product Code Lpc Advisory Committee Cardiovascular Supplement Typereal Time Process 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 Numbers116 Date Received06 17 2022 Decision Date08 19 2022 Product Code Lpc Advisory Committee Cardiovascular Supplement Typereal Time Process 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 Filings

Device Company	Device	Date
PMA P910001S116 SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS116 Date Received06/17/2022 Decision Date08/19/2022 Product Code LPC  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	ELCA Coronoary Laser Atherectomy Catheter	2022-08-19