Impulse Dynamics Usa Inc

FDA Filings

This page includes the latest FDA filings for Impulse Dynamics Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007805252
• FEI Number: 3007805252
• Name: IMPULSE DYNAMICS USA INC
• Owner & Operator: Impusle Dynamics USA Inc
• Contact Address: 1 Blue Hill Plaza, Floor 16, Suite 11610; Pearl River NY 10965 US
• Official Correspondent:
  • Deborah Morley
  • x-845-3592389-205
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1 Blue Hill Plaza, Floor 16, Suite 11610; Pearl River, NY 10965 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3012563838
• FEI Number: 3012563838
• Name: Impulse Dynamics USA Inc
• Owner & Operator: Impusle Dynamics USA Inc
• Contact Address: 1 Blue Hill Plaza, Floor 16, Suite 11610; Pearl River NY 10965 US
• Official Correspondent:
  • Deborah Morley
  • x-845-3592389-205
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 523 Fellowship Road Suite 230; Mount Laurel, NJ 08054 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 00810003380142 Impulse Dynamics (usa) Inc.	OPTIMIZER 10-B502-3-XX	2024-03-05
GUDID 00810003380135 Impulse Dynamics (usa) Inc.	Vesta 10-F302-3-XX	2024-03-05
GUDID 00810003380074 Impulse Dynamics (usa) Inc.	Guardio 10-F311-3-XX	2023-04-04
GUDID 00810003380098 Impulse Dynamics (usa) Inc.	OPTIMIZER 10-B501-3-XX	2022-05-09
GUDID 00810003380081 Impulse Dynamics (usa) Inc.	Vesta 10-F301-3-XX	2022-05-09
GUDID 00810003380067 Impulse Dynamics (usa) Inc.	Intelio 10-A701-3-XX	2022-05-09
PMA P180036S011 Impulse Dynamics (USA), Inc.	OPTIMIZER Smart Mini System	2021-12-16
PMA P180036S010 Impulse Dynamics (USA), Inc.	OPTIMIZER Smart System	2021-10-15
PMA P180036S008 Impulse Dynamics (USA), Inc.	Optimizer Smart System and Optimizer Smart Mini System	2021-10-06
PMA P180036S007 Impulse Dynamics (USA), Inc.	OPTIMIZER Smart Mini System	2021-07-30
GUDID 00810003380050 Impulse Dynamics (usa) Inc.	OPTIMIZER™ 10-B411-3-XX	2021-01-05
GUDID 00810003380043 Impulse Dynamics (usa) Inc.	OPTIMIZER™ 10-F202-3-XX	2021-01-05
PMA P180036S006 Impulse Dynamics (USA), Inc.	OPTIMIZER Smart System (2-Lead configuration)	2020-12-30
PMA P180036S005 Impulse Dynamics (USA), Inc.	OPTIMIZER Smart System	2020-09-02
PMA P180036S004 Impulse Dynamics (USA), Inc.	OPTIMIZER Smart IPG	2020-02-28
PMA P180036S003 Impulse Dynamics (USA), Inc.	OPTIMIZER Smart System	2019-10-23
PMA P180036S002 Impulse Dynamics (USA), Inc.	OPTIMIZER Smart System	2019-08-13
PMA P180036S001 Impulse Dynamics (USA), Inc.	Optimizer Smart System (IPG)	2019-05-21
GUDID 00810003380029 IMPULSE DYNAMICS (USA) INC.	OPTIMIZER® 10-F202-3-US	2019-04-22
GUDID 00810003380012 IMPULSE DYNAMICS (USA) INC.	OMNI™ II 10-A604-3-US	2019-04-22
GUDID 00810003380005 IMPULSE DYNAMICS (USA) INC.	OPTIMIZER® 10-B411-3-US	2019-04-22
PMN P180036 | QFV Impulse Dynamics USA Inc [Impusle Dynamics USA Inc]	OPTIMIZER SMART SYSTEM	2019-03-25
PMN P180036 | QFV IMPULSE DYNAMICS USA INC [Impusle Dynamics USA Inc]	OPTIMIZER SMART SYSTEM	2019-03-25
PMA P180036 Impulse Dynamics (USA), Inc.	OPTIMIZER Smart System	2019-03-21

Similar & Related FDA Registered Companies

• 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

Related Finance Registrations

CAGE Code	7BRM6	IMPULSE DYNAMICS (USA) INC. IMPULSE DYNAMICS
S.A.M. Registration	7BRM6 [878519342]	IMPULSE DYNAMICS (USA) INC.