Harmony Transcatheter Pulmonary System

FDA Premarket Approval P200046 S002

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

Additional verification of the date of manufacture and use by date for devices undergoing rework activities

DeviceHarmony Transcatheter Pulmonary System
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantMedtronic, Inc.
Date Received2021-04-23
Decision Date2021-05-21
PMAP200046
SupplementS002
Product CodeNPV 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
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
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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