Harmony TPV System

FDA Premarket Approval P200046 S004

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

Automation of the bioburden reduction process

DeviceHarmony TPV System
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantMedtronic, Inc.
Date Received2021-07-01
Decision Date2021-07-07
PMAP200046
SupplementS004
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
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

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