MELODY®

GUDID 00613994663962

VALVE PB1018 MELODY HDE

MEDTRONIC, INC.

Pulmonary transcatheter heart valve bioprosthesis
Primary Device ID00613994663962
NIH Device Record Keybfff5075-154a-4aaa-ad24-fc510d260d8d
Commercial Distribution Discontinuation2016-01-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMELODY®
Version Model NumberPB1018
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994663962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPVPulmonary valve prosthesis percutaneously delivered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-04
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00763000004101 - NA2025-09-02 COMMUNICATOR TM90T0 TDD PROX
00199150042050 - NA2025-09-01 CUSTOM PACK SSHY12R43R HLN BB8G55R1
00199150042104 - NA2025-09-01 CUSTOM PACK BB12R13R1 HLN SUTT PED
00199150042111 - NA2025-09-01 CUSTOM PACK BB12Q88R1 HLN INF SUTTE
00763000998271 - Affera™ Integrated Mapping System2025-09-01 MAP SYS AFR-00016 IMPEDANCE US PLX
00199150042005 - NA2025-08-29 CUSTOM PACK BB7E29R28 EVL 3/8
00199150042012 - NA2025-08-29 CUSTOM PACK BB11L88R8 EVL SUPPRT SM
00199150042029 - NA2025-08-29 CUSTOM PACK BB12P62R3 EVL 1/4

Trademark Results [MELODY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MELODY
MELODY
98296010 not registered Live/Pending
Melody LLC
2023-12-02
MELODY
MELODY
97880354 not registered Live/Pending
Advanced Inventory Management, Inc.
2023-04-10
MELODY
MELODY
97818169 not registered Live/Pending
Milk Care Co. Inc.
2023-03-01
MELODY
MELODY
97675542 not registered Live/Pending
Laboratorios Incobra, S.A.
2022-11-14
MELODY
MELODY
97113979 not registered Live/Pending
Odin Fashion Corporation
2021-11-08
MELODY
MELODY
90118362 not registered Live/Pending
GSH Trademarks Limited
2020-08-17
MELODY
MELODY
90095747 not registered Live/Pending
An, Sengho
2020-08-05
MELODY
MELODY
88478010 not registered Live/Pending
KEUM & EUN, INC.
2019-06-18
MELODY
MELODY
88477998 not registered Live/Pending
KEUM & EUN, INC.
2019-06-18
MELODY
MELODY
88321706 not registered Dead/Abandoned
Steven L Brady
2019-03-01
MELODY
MELODY
87852422 not registered Dead/Abandoned
KEUM & EUN INC.
2018-03-27
MELODY
MELODY
87259970 not registered Dead/Abandoned
Speak Music Inc
2016-12-07

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.