BAROSTIM NEO® System

FDA Premarket Approval P180050 S008

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 NEO® System
Generic NameStimulator, Carotid Sinus Nerve
ApplicantCVRx, 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
Date Received2022-12-23
Decision Date2023-01-20
PMAP180050
SupplementS008
Product CodeDSR 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressCVRx, INC.
9201 West Broadway Ave, Ste 650
minneapolis, 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 Combination ProductNo Approval Order Statement  
Approval Of The Revised Protocol For The Post-approval Study Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P180050.

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

© 2023 FDA.report
This site is not affiliated with or endorsed by the FDA.