Silk Road Medical Inc1213 Innsbruck Drivesunnyvale Ca 94089 Pma Numberp140026 Supplement Numbers025 Date Received11 21 2022 Decision Date12 16 2022 Product Code Nim Advisory Committee Cardiovascular Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Silk Road Medical Inc1213 Innsbruck Drivesunnyvale Ca 94089 Pma Numberp140026 Supplement Numbers025 Date Received11 21 2022 Decision Date12 16 2022 Product Code Nim 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.

FDA Filings

Device Company	Device	Date
PMA P140026S025 SILK ROAD MEDICAL, INC1213 Innsbruck Drivesunnyvale, CA 94089 PMA NumberP140026 Supplement NumberS025 Date Received11/21/2022 Decision Date12/16/2022 Product Code NIM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	ENROUTE® Transcarotid Stent System	2022-12-16