Cvrx Inc

FDA Filings

This page includes the latest FDA filings for Cvrx 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	3007972010
FEI Number	3007972010
Name	CVRX, INC.
Owner & Operator	CVRx, Inc.
Contact Address	9201 West Broadway Avenue, Suite 650 Minneapolis MN 55445 US
Official Correspondent	Dawn Biegert x-763-4162356-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	9201 W Broadway Ave Ste 650 Minneapolis, MN 55445 US
Establishment Type	Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P180050S001 CVRx, INC.	Barostim NEO System, Barostim NEO2 System	2021-12-17
PMN P180050 \| DSR CVRX, INC.	BAROSTIM NEO	2019-09-26
PMN P180050 \| DSR CVRX, INC.	BAROSTIM NEO System	2019-09-26
GUDID 00859144004470 CVRX, INC.	BAROSTIM NEO 100063-222	2019-08-30
GUDID 00859144004463 CVRX, INC.	BAROSTIM NEO 100063-212	2019-08-30
GUDID 00859144004456 CVRX, INC.	BAROSTIM Lead Repair Kit 100056-202	2019-08-30
GUDID 00859144004449 CVRX, INC.	BAROSTIM Programmer 100055-202	2019-08-30
GUDID 00859144004432 CVRX, INC.	BAROSTIM NEO 100054-202	2019-08-30
PMA P180050 CVRx, INC.	BAROSTIM NEO® System	2019-08-16
GUDID 00859144004234 CVRX, INC.	100033-301 100033-301	2018-03-29
GUDID 00859144004227 CVRX, INC.	100034-301 100034-301	2018-03-29
GUDID 00859144004210 CVRX, INC.	Neo Legacy 100053-301	2018-03-29
GUDID 00859144004203 CVRX, INC.	100056-301 100056-301	2018-03-29
GUDID 00859144004128 CVRX, INC.	100055-102 100055-102	2018-03-29
PMN H130007 \| DSR CVRX, INC.	BAROSTIM LEGACY, BAROSTIM LEGACY System	2015-12-09

Similar & Related FDA Registered Companies

CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS008 Date Received12/23/2022 Decision Date01/20/2023 Product Code DSR Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS007 Date Received05/31/2022 Decision Date06/27/2022 Product Code DSR Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS006 Date Received05/20/2022 Decision Date06/14/2022 Product Code DSR Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS005 Date Received03/28/2022 Decision Date04/26/2022 Product Code DSR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS002 Date Received09/20/2021 Decision Date04/14/2022 Product Code DSR Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS004 Date Received03/17/2022 Decision Date04/12/2022 Product Code DSR Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	66FR5	CVRX, INC.
CAGE Code	66FR5	CVRX, INC.
S.A.M. Registration	66FR5 [52373680]	CVRX, INC.
SEC	0001235912	CVRx, Inc. of DELAWARE