Harmony Transcatheter Pulmonary Valve

FDA Premarket Approval P200046 S006

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Establishment of an in-process shelf life for fixed tissue placed in storage

DeviceHarmony Transcatheter Pulmonary Valve
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantMedtronic, Inc.
Date Received2021-12-02
Decision Date2021-12-16
Product CodeNPV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
S006 2021-12-02 30-day Notice
S005 2021-07-09 30-day Notice
S004 2021-07-01 30-day Notice
S002 2021-04-23 Special (immediate Track)
S001 2021-04-05 30-day Notice


Device IDPMASupp
00763000341367 P200046 000
00763000338992 P200046 000
00763000338985 P200046 000

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