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EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30070632183007063218EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd1N2026-01-0135 Changi North Crescent Changi South East SG 499641

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1100901251947745P860057EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESDYE1991-09-26
1100901063643663P230013Edwards EVOQUE Tricuspid Valve Replacement SystemNPW2024-02-01
1100901875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM2022-09-14
1100901675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV2020-08-31
1100901356742917P150048EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)LWR2017-06-29
1100901430629239P150036EDWARDS INTUITY ELITE VALVE SYSTEMLWR2016-08-12
1100901156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
1100901890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LWR22017-06-29
NPT22015-06-17
NKM 12022-09-14
NPV 12020-08-31
DYE11991-09-26