Medinol L T D Kiryat Atidim Bldg 8pob 58165tel Aviv 61581 Pma Numberp170008 Supplement Numbers039 Date Received03 22 2022 Decision Date04 20 2022 Product Code Niq 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 Medinol L T D Kiryat Atidim Bldg 8pob 58165tel Aviv 61581 Pma Numberp170008 Supplement Numbers039 Date Received03 22 2022 Decision Date04 20 2022 Product Code Niq 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 P170008S039 Medinol, Ltd.kiryat Atidim, Bldg. 8pob 58165tel Aviv 61581 PMA NumberP170008 Supplement NumberS039 Date Received03/22/2022 Decision Date04/20/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	EluNIR™ Ridaforolimus Eluting Coronary Stent System	2022-04-20