PMA P180050S011

Device: BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si
Applicant: Cvrx, Inc.
PMA number: P180050
Supplement: S011
Product code: DSR
Decision date: 2024-04-19
Classification: Cardiovascular
Generic name: Stimulator, carotid sinus nerve
Approval order statement: labeling update to warnings and instructions regarding interaction with co-implants

Current openFDA PMA Record#

Device: BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si
Applicant: Cvrx, Inc.
PMA number: P180050
Supplement: S011
Product code: DSR
Generic name: Stimulator, carotid sinus nerve
Decision date: 2024-04-19
Decision code: APPR
Date received: 2023-11-09
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: labeling update to warnings and instructions regarding interaction with co-implants