Impulse Dynamics Usa Inc 30 Ramland Road South Suite 204orangeburg Ny 10962 Pma Numberp180036 Supplement Numbers015 Date Received07 22 2022 Decision Date08 18 2022 Product Code Qfv Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Impulse Dynamics Usa Inc 30 Ramland Road South Suite 204orangeburg Ny 10962 Pma Numberp180036 Supplement Numbers015 Date Received07 22 2022 Decision Date08 18 2022 Product Code Qfv Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol 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 P180036S015 Impulse Dynamics (USA), Inc.30 Ramland Road South, Suite 204orangeburg, NY 10962 PMA NumberP180036 Supplement NumberS015 Date Received07/22/2022 Decision Date08/18/2022 Product Code QFV  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No	OPTIMIZER Smart, OPTIMIZER Smart Mini	2022-08-18