Barostim NEO System, Barostim NEO2 System

FDA Premarket Approval P180050 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval to add an alternate implantable pulse generator model 2104 and associated model 9010 programmer system software.

DeviceBarostim NEO System, Barostim NEO2 System
Generic NameStimulator, Carotid Sinus Nerve
ApplicantCVRx, INC.
Date Received2021-01-19
Decision Date2021-12-17
PMAP180050
SupplementS001
Product CodeDSR 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CVRx, INC. 9201 West Broadway Ave, Ste 650 minneapolis, MN 55445

Supplemental Filings

Supplement NumberDateSupplement Type
P180050Original Filing
S008 2022-12-23 Normal 180 Day Track No User Fee
S007 2022-05-31 Normal 180 Day Track No User Fee
S006 2022-05-20 Normal 180 Day Track No User Fee
S005 2022-03-28 30-day Notice
S004 2022-03-17 Normal 180 Day Track No User Fee
S003
S002 2021-09-20 Normal 180 Day Track
S001 2021-01-19 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00859144004623 P180050 001
00859144004630 P180050 002
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