BAROSTIM NEO® System
FDA premarket approval P180050 · decided 2019-08-16
Approval details
- PMA number
- P180050
- Trade name
- BAROSTIM NEO® System
- Generic name
- Stimulator, carotid sinus nerve
- Applicant
- Cvrx, Inc.
- Date received
- 2018-12-20
- Decision date
- 2019-08-16
- Days to decision
- 239 days
- Decision code
- APPR
- Product code
- DSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for The BAROSTIM NEO System. The device is indicated for the improvement of symptoms of heart failure. quality of life, six-minute hall walk and functional status, for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction <= 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) accordin
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.