FDA.reportPublic FDA data

Edwards Lifesciences

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30152875733015287573Edwards Lifesciences1N2027-01-01Zona Franca La Lima, De la entrada de Pequeno Mundo 100 mts oest Finca 31 y 32 Guadalupe Cartago CR 30106

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2281261251947745P860057EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESDYE1991-09-26
2281261356742917P150048EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)LWR2017-06-29
2281261156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
2281261268556230K926138CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RINGKRH1993-06-22
2281261565751356K923367COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600KRH1993-01-06
2281261794933339K251982Edwards MC3 Tricuspid annuloplasty ring (4900)KRH2025-09-23
2281261623759230K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH2025-09-17
2281261301009376K192762Physio Flex Annuloplasty RingKRH2019-12-16
2281261294418618K103520CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RINGKRH2011-06-24
2281261207544903K083623CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100KRH2009-04-15
2281261212390437K083470CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200KRH2009-01-23
2281261240403258K020864EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900KRH2002-04-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KRH92025-09-23
LWR12017-06-29
NPT12015-06-17
DYE11991-09-26

PMN#