Harmony™ TPV System

FDA Premarket Approval P200046

Pre-market Approval Supplement Details

Approval for the harmony™ transcatheter pulmonary valve (tpv) system. This device is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation (i. E. , severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction >= 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.

DeviceHarmony™ TPV System
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantMedtronic, Inc.
Date Received2020-11-18
Decision Date2021-03-26
PMAP200046
SupplementS
Product CodeNPV 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic, Inc. 3576 Unocal Place building A santa Rosa, CA 95403

Supplemental Filings

Supplement NumberDateSupplement Type
P200046Original Filing
S001 2021-04-05 30-day Notice

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.