Barostim™ System

FDA Premarket Approval P180050 S002

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

DeviceBarostim™ System
Generic NameStimulator, Carotid Sinus Nerve
ApplicantCVRx, 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
Date Received2021-09-20
Decision Date2022-04-14
PMAP180050
SupplementS002
Product CodeDSR 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressCVRx, INC.
9201 West Broadway Ave, Ste 650
minneapolis, 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 Combination ProductNo Approval Order Statement  
Approval To Add Model 9020 Barostim™ Programmer As An Alternate Programmer And Additional Branding Updates.

Supplemental Filings

Supplement NumberDateSupplement Type
P180050Original Filing
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

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