Boston Scientific Corp Two Scimed Placemaple Grove Mn 55311 1566 Pma Numberp900056 Supplement Numbers197 Date Received01 28 2022 Decision Date02 25 2022 Product Code Mcx 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 Boston Scientific Corp Two Scimed Placemaple Grove Mn 55311 1566 Pma Numberp900056 Supplement Numbers197 Date Received01 28 2022 Decision Date02 25 2022 Product Code Mcx 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 P900056S197 Boston Scientific Corp.two Scimed Placemaple Grove, MN 55311-1566 PMA NumberP900056 Supplement NumberS197 Date Received01/28/2022 Decision Date02/25/2022 Product Code MCX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Rotablator Rotational Angioplasty System Guidewire	2022-02-25