Melody™ Transcatheter Pulmonary Valve System

FDA Premarket Approval P140017 S021

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

DeviceMelody™ Transcatheter Pulmonary Valve System
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantMEDTRONIC Inc.8200 Coral Sea Street Nemvs83mounds View, MN 55112 PMA NumberP140017 Supplement NumberS021 Date Received02/28/2022 Decision Date03/01/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-02-28
Decision Date2022-03-01
PMAP140017
SupplementS021
Product CodeNPV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMEDTRONIC Inc.
8200 Coral Sea Street Ne
mvs83
mounds View, MN 55112 PMA NumberP140017 Supplement NumberS021 Date Received02/28/2022 Decision Date03/01/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
use Of A New Data Management System For Microbiology Laboratory Test Data And Data Reporting At The Medtronic Tijuana Facility For The Evolut R, Evolut PRO, Evolut PRO+, And Evolut FX Transcatheter Aortic Valves (TAVs), Harmony And Melody Transcatheter Pulmonic Valves (TPV), And Avalus Bioprosthesis Products

Supplemental Filings

Supplement NumberDateSupplement Type
P140017Original Filing
S023 2022-11-16 30-day Notice
S022 2022-07-20 30-day Notice
S021 2022-02-28 30-day Notice
S020 2022-01-27 30-day Notice
S019 2021-07-29 30-day Notice
S018
S017 2019-10-01 30-day Notice
S016
S015 2019-06-20 30-day Notice
S014 2018-11-13 Normal 180 Day Track No User Fee
S013
S012 2018-10-01 30-day Notice
S011 2018-09-26 Real-time Process
S010 2017-12-01 30-day Notice
S009
S008 2017-09-11 30-day Notice
S007 2017-04-19 30-day Notice
S006 2016-11-23 Normal 180 Day Track No User Fee
S005 2016-09-01 Panel Track
S004 2016-04-25 Normal 180 Day Track
S003 2016-04-08 30-day Notice
S002 2016-03-23 30-day Notice
S001 2015-06-17 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00643169588455 P140017 000
00643169588448 P140017 000
00643169588431 P140017 000
00643169588196 P140017 000
00643169588189 P140017 000
00643169713895 P140017 004
00643169713901 P140017 004
00643169713888 P140017 004

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