Product code NPV

Product
Radiation Emitting Electronic Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical De
Definition
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Description
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
Regulation number
Radiation type
Radiation Emitting Electronic Product Codes // Qui
Applicable standards
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -

Current FDA Classification

Device name
Pulmonary Valve Prosthesis Percutaneously Delivered
Medical specialty
Unknown
Device class
f
Review panel
CV
Implant
Y
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.

Related Records

Related PMA Records

PMADeviceApplicantDecision date
P140017S017Evolut R and CoreValve Evolut PRO SystemsMEDTRONIC Inc.2019-10-30
P140017S015Melody Transcatheter Pulmonary Valve (TPV) SystemMEDTRONIC Inc.2019-07-17
P140017S014Melody TPV SystemMEDTRONIC Inc.2019-04-18
P140017S011Melody TPV SystemMEDTRONIC Inc.2018-10-30
P140017S012MelodyMEDTRONIC Inc.2018-10-28
P140017S010Melody TPV SystemMEDTRONIC Inc.2017-12-14
P140017S008Melody Transcatheter Pulmonary Valve (TPV)MEDTRONIC Inc.2017-10-03
P140017S006MELODY TRANSCATHETER PULMONARY VALVE , ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)MEDTRONIC Inc.2017-05-22
P140017S007Melody Transcatheter Pulmonary Valve SystemMEDTRONIC Inc.2017-05-19
P140017S005MELODY TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE DMEDTRONIC Inc.2017-02-24
P140017S004ENSEMBLE II TRANSCATHETER VALVE DELIVERY SYSTEMMEDTRONIC Inc.2016-09-12
P140017S003MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)MEDTRONIC Inc.2016-05-04
P140017S002MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)MEDTRONIC Inc.2016-03-25
P140017S001MELODY TRANSCATHETER PULMONARY VALVEMEDTRONIC Inc.2015-07-15
P140017MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)MEDTRONIC Inc.2015-01-27

Related GUDID Devices

Primary DIBrandCompanyPublished
00690103221329Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLC2026-02-17
00690103221336Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLC2026-02-17
00690103221343Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLC2026-02-17
00690103221312Edwards SAPIEN 3 transcatheter pulmonic valve delivery systemEdwards Lifesciences LLC2026-02-17
00690103210873EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM)Edwards Lifesciences LLC2022-01-04
00690103210866THE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEMEdwards Lifesciences LLC2021-12-23
00763000338985Harmony™MEDTRONIC, INC.2021-04-22
00763000338992Harmony™MEDTRONIC, INC.2021-04-22
00763000341367Harmony™MEDTRONIC, INC.2021-04-22
00643169713895Ensemble™ llMEDTRONIC, INC.2016-10-31
00643169713888Ensemble™ llMEDTRONIC, INC.2016-10-31
00643169713901Ensemble™ llMEDTRONIC, INC.2016-10-31
00643169588189Melody™ TPVMEDTRONIC, INC.2015-02-24
00643169588196Melody™ TPVMEDTRONIC, INC.2015-02-24
00643169588431Ensemble™MEDTRONIC, INC.2015-02-24
00643169588448Ensemble™MEDTRONIC, INC.2015-02-24
00643169588455Ensemble™MEDTRONIC, INC.2015-02-24
00613994663962MELODY®MEDTRONIC, INC.2014-09-23
00613994665980ENSEMBLE™MEDTRONIC, INC.2014-09-23
00613994665997ENSEMBLE™MEDTRONIC, INC.2014-09-23
00613994666000ENSEMBLE™MEDTRONIC, INC.2014-09-23
00643169415874Melody™ TPVMEDTRONIC, INC.2014-09-23
00643169415850Melody™ TPVMEDTRONIC, INC.2014-09-23
00643169415768ENSEMBLE™MEDTRONIC, INC.2014-09-23
00643169415744ENSEMBLE™MEDTRONIC, INC.2014-09-23
00643169415720ENSEMBLE™MEDTRONIC, INC.2014-09-23