Bostonscientific4100 Hamline Avenue Northst Paul Mn 55112 Pma Numberp150012 Supplement Numbers136 Date Received12 07 2022 Decision Date12 14 2022 Product Codes Lwp Nvn 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 Bostonscientific4100 Hamline Avenue Northst Paul Mn 55112 Pma Numberp150012 Supplement Numbers136 Date Received12 07 2022 Decision Date12 14 2022 Product Codes Lwp Nvn 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 P150012S136 BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS136 Date Received12/07/2022 Decision Date12/14/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	ESSENTIO™ MRI SR, ESSENTIO™ MRI DR, ESSENTIO™ MRI EL DR, PROPONENT, ACCOLADE™ MRI SR, ACCOLADE™ MRI DR, ACCOLADE™ MRI EL	2022-12-14