Product code NKM

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
Mitral Valve Repair Devices
Medical specialty
Unknown
Device class
3
Review panel
CV
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.

Related Records

Related PMA Records

PMADeviceApplicantDecision date
P100009S036MitraClip G4 Clip Delivery SystemABBOTT VASCULAR INC.2019-09-30
P100009S035MitraClip NTR, XTR and G4 Clip Delivery SystemABBOTT VASCULAR INC.2019-09-11
P100009S034MitraClip NT, NTR, XTR, G4 Clip Delivery SystemABBOTT VASCULAR INC.2019-08-30
P100009S033MitraClip XTR Clip Delivery SystemABBOTT VASCULAR INC.2019-07-26
P100009S032MitraClip NT, NTR, and XTR Clip Delivery SystemABBOTT VASCULAR INC.2019-07-18
P100009S030MitraClip System (NTR and XTR)ABBOTT VASCULAR INC.2019-06-03
P100009S028MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery SystemABBOTT VASCULAR INC.2019-03-14
P100009S026MitraClip System (NT)ABBOTT VASCULAR INC.2018-08-13
P100009S027MitraClip Clip Delivery System (NTR and XTR)ABBOTT VASCULAR INC.2018-06-29
P100009S025MitraClip System (NTR and XTR)ABBOTT VASCULAR INC.2018-05-23
P100009S024MitraClip and MitraClip NT Clip Delivery SystemABBOTT VASCULAR INC.2017-06-22
P100009S023MitraClip Delivery SystemABBOTT VASCULAR INC.2017-04-28
P100009S022MitraClip NT Clip Delivery SystemABBOTT VASCULAR INC.2017-04-13
P100009S018MITRACLIP CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2016-08-09
P100009S020MITRACLIP AND MITRACLIP NT CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2016-07-05
P100009S019MITRACLIP NT CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2016-06-24
P100009S015MITRACLIP NT CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2016-05-10
P100009S017MITRACLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2016-03-30
P100009S010MITRACLIP CLIP DELIVERY SYSTEM AND MITRACLIP STEERABLE GUIDE CATHETERABBOTT VASCULAR INC.2015-11-18
P100009S014MITRACLIP CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2015-10-29
P100009S013MITRACLIP CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2015-10-15
P100009S012MITRACLIP CLIP DELIVERY SYSTEM; MITRACLIP STEERABLE GUIDE CATHETERABBOTT VASCULAR INC.2015-07-23
P100009S011MITRACLIP CLIP DELIVERY SYSTEM, MITRACLIP STEERABLE GUIDE CATHETERABBOTT VASCULAR INC.2015-05-07
P100009S009MITRACLIP CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2014-12-22
P100009S008MITRACLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2014-12-17
P100009S007MITRACLIP CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2014-08-13
P100009S006MITRACLIP CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2014-07-16
P100009S004MITRACLIP CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2014-07-09
P100009S001MIRACLIP CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2014-06-13
P100009S005MITRACLIP CLIP DELIVERY SYSTEMABBOTT VASCULAR INC.2014-05-22

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00690103216967PASCAL PRECISIONEdwards Lifesciences LLC2022-09-19
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08717648230943MITRACLIPABBOTT VASCULAR INC.2019-11-11
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08717648230981MITRACLIPABBOTT VASCULAR INC.2019-11-11
08717648231001MITRACLIPABBOTT VASCULAR INC.2019-11-11
08717648226342MITRACLIPABBOTT VASCULAR INC.2018-07-09
08717648226366MITRACLIPABBOTT VASCULAR INC.2018-07-09
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