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
S013 2022-11-29 30-day Notice
S012 2022-10-31 30-day Notice
S011 2022-07-26 30-day Notice
S010
S009 2022-05-16 30-day Notice
S008 2022-03-11 Normal 180 Day Track No User Fee
S007 2022-02-28 30-day Notice
S006 2021-12-02 30-day Notice
S005 2021-07-09 30-day Notice
S004 2021-07-01 30-day Notice
S003
S002 2021-04-23 Special (immediate Track)
S001 2021-04-05 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00763000341367 P200046 000
00763000338992 P200046 000
00763000338985 P200046 000

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