Melody Transcatheter Pulmonary Valve System

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Premarket Approval P140017 S007

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

Changes to endotoxin and bioburden testing for the ensemble and ensemble ii delivery systems.

DeviceMelody Transcatheter Pulmonary Valve System
Classification NamePulmonary Valve Prosthesis Percutaneously Delivered
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantMEDTRONIC Inc.
Date Received2017-04-19
Decision Date2017-05-19
PMAP140017
SupplementS007
Product CodeNPV
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC Inc. 8200 Coral Sea Street Ne mvs83 mounds View, MN 55112

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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