Boston Scientific Corp Two Scimed Placemaple Grove Mn 55311 1566 Pma Numberp900056 Supplement Numbers199 Date Received03 30 2022 Decision Date04 28 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 Numbers199 Date Received03 30 2022 Decision Date04 28 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 P900056S199 Boston Scientific Corp.two Scimed Placemaple Grove, MN 55311-1566 PMA NumberP900056 Supplement NumberS199 Date Received03/30/2022 Decision Date04/28/2022 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, ROTAPRO Rotational Artherectomy System, ROTAWIRE Drive	2022-04-28