FDA.reportPublic FDA data

CVRX, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30079720103007972010CVRX, INC.1N2026-01-019201 W Broadway Ave Ste 650 Minneapolis MN US 55445

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00859144004432BAROSTIM NEO - BAROSTIM NEO Model 2102 Implantable Pulse Generator (US Commercial)7634167457acrouse@cvrx.com
00859144004449BAROSTIM Programmer - Model 9010 Programmer System (US Commercial)7634167457acrouse@cvrx.com
00859144004470BAROSTIM NEO - BAROSTIM NEO Model 1037 Carotid Sinus Lead Kit7634167457acrouse@cvrx.com
00859144004623Barostim NEO2 - Model 2104 Barostim NEO2 Implantable Pulse Generator763-416-7457acrouse@cvrx.com
00859144004630Barostim - Model 9020 Barostim Programmer System763-416-7457acrouse@cvrx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1253331344007448P180050BAROSTIM NEO® SystemDSR2019-08-16
1253331487140494H130007

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSR12019-08-16

PMA#

BAROSTIM NEO® System

2023-01-20

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 D...

Barostim System

2022-06-27

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 D...

Barostim System

2022-06-14

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 D...

Barostim System

2022-04-26

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...

Barostim™ System

2022-04-14

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 ...

Barostim System

2022-04-12

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 D...

GUDID#