PMA P180050S012

Device: BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Le
Applicant: Cvrx, Inc.
PMA number: P180050
Supplement: S012
Product code: DSR
Decision date: 2024-01-11
Classification: Cardiovascular
Generic name: Stimulator, carotid sinus nerve
Approval order statement: a change in the manufacturing facility of the supplier of the Model 2104 Implantable Pulse Generator header component

Current openFDA PMA Record#

Device: BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Le
Applicant: Cvrx, Inc.
PMA number: P180050
Supplement: S012
Product code: DSR
Generic name: Stimulator, carotid sinus nerve
Decision date: 2024-01-11
Decision code: OK30
Date received: 2023-12-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change in the manufacturing facility of the supplier of the Model 2104 Implantable Pulse Generator header component