FDA.reportPublic FDA data

Ed

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12873941287394Edap Technomed Inc.1Y2026-01-015321 Industrial Oaks Blvd Suite 110 Austin TX US 78735
16413031000118860EDUSA CORPORATION1Y2026-01-0111751 ALAMEDA STREET Socorro TX US 79927
16498793001238589EDWARD HINES VA HOSPITAL1N2026-01-015000 South 5th Avenue Office of Information & Technology, Bldg 215 HINES IL US 60141
20156912015691EDWARDS LIFESCIENCES LLC1Y2026-01-01ONE EDWARDS WAY IRVINE CA US 92614
24319082431908EDLAW PHARMACEUTICALS, INC.1N2026-01-01195-B CENTRAL AVE. E Farmingdale NY US 11735
26480452648045EDWARDS LIFESCIENCES TECHNOLOGY SARL1N2026-01-01STATE ROAD 402, KM 1.4, Industrial Park ANASCO PR US 00610
80433233006078362Edward Conlon1N2026-01-01189 Main St Ste 31 Milford MA US 01757
96124483002806876EDAP TMS France SA1N2026-01-014 rue du Dauphine Vaulx en Velin Rhone FR 69120
96159923001104292Edoardo Mastrovito1N2026-01-011 Corporate Drive #400 Shelton CT US 06484
96812103003667632Edward Spehar1N2026-01-01581 Inner Circle The Villages FL US 32162
30002790433000279043EDMONDS DENTAL PROSTHETICS, INC.1N2026-01-012065 W Woodland St Springfield MO US 65807
30038510733003851073Edward Ma1N2026-01-011469 Rolling Knoll Road Diamond Bar CA US 91765
30039005963003900596Ed Herr1N2026-01-01611 17th Street West Jasper AL US 35501
30046325233004632523Eduard Gerlach Gmbh1N2026-01-01Baeckerstrasse 4-8 Luebbecke North Rhine-Westphalia DE 32312
30048571103004857110EDDA TECHNOLOGY, INC.1N2026-01-015 Independence Way Suite 210 Princeton NJ US 08540
30053959533005395953EDMONDO N. ROARK1N2026-01-01624 Athens Avenue Cincinnati, Ohio Cincinnati OH US 45226
30057484503005748450EDSER INSOLES S.L.1N2026-01-01C/GALL,47,ENTLO.POL.IND. GALL BARCELONA ESPLUGUES DE LLOBREGAT Barcelona ES 08950
30064056603006405660Eddie Catalfamo1N2026-01-012255 Glades Rd Ste 324A Boca Raton FL US 33431
30070632183007063218EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd1N2026-01-0135 Changi North Crescent Changi South East SG 499641
30085004781713910Edwards Lifesciences LLC1Y2026-01-0112050 Lone Peak Parkway Draper UT US 84020
30087192223008719222Edward Roles1N2026-01-01311 S Wacker Dr Ste 4100 Chicago IL US 60606
30088081223008808122Edwin Lindsay1N2026-01-0110124 Nw 53rd St Sunrise FL US 33351
30090235533009023553EDEVICE1N2026-01-01Parc Cadera Sud - Bat P2 Avenue Ariane Merignac Gironde FR 33700
30091179913009117991EDELWEISS DENTISTRY PRODUCTS GMBH1N2026-01-01Dammstrasse 68 Wolfurt Vorarlberg AT 6922
30094994783009499478EDAN Diagnostics, Inc.1Y2026-01-019918 Via Pasar San Diego CA US 92126

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
573211625333749P870077CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESISDYE1991-09-25
573211797178365P870056CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625DYE1991-09-25
573211251947745P860057EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESDYE1991-09-26
1100901251947745P860057EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESESDYE1991-09-26
573211617674250P250019SAPIEN M3 Transcatheter Mitral Valve Replacement SystemNPU2025-12-22
1178531617674250P250019SAPIEN M3 Transcatheter Mitral Valve Replacement SystemNPU2025-12-22
573211063643663P230013Edwards EVOQUE Tricuspid Valve Replacement SystemNPW2024-02-01
1100901063643663P230013Edwards EVOQUE Tricuspid Valve Replacement SystemNPW2024-02-01
1178531063643663P230013Edwards EVOQUE Tricuspid Valve Replacement SystemNPW2024-02-01
573211875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM2022-09-14
1100901875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM2022-09-14
1178531875368167P220003PASCAL Precision Transcatheter Valve Repair SystemNKM2022-09-14
573211675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV2020-08-31
1100901675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV2020-08-31
1178531675241087P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery SystemNPV2020-08-31
573211356742917P150048EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)LWR2017-06-29
1100901356742917P150048EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)LWR2017-06-29
573211430629239P150036EDWARDS INTUITY ELITE VALVE SYSTEMLWR2016-08-12
1100901430629239P150036EDWARDS INTUITY ELITE VALVE SYSTEMLWR2016-08-12
1178531430629239P150036EDWARDS INTUITY ELITE VALVE SYSTEMLWR2016-08-12
573211156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
1100901156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
1178531156634157P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2015-06-17
573211890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16
1100901890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16
1178531890333329P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIESNPT2014-06-16
573211446461453P010041CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)DYE2002-06-24
573211598766427P000007EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500PDYE2001-02-27
1178531713104232K994243DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIPDWF2000-05-05
157141594570512K992001TRAY-LINKELW1999-11-02
157141826112793K991450ETCHING GELEBF1999-07-09
157141781446695K991442LC MICROFILLEBF1999-06-03
1178532066842590K990396T-ANASTAFLODWF1999-10-01
157141374674517K990108LC FLOWFILLEBF1999-03-09
157141540115942K984484LC MICROHYBRIDEBF1999-01-20
157141205185478K984483A-SOFT RELINEREBI1999-02-18
157141211775224K984097DC-COREEBF1999-02-09
573211003852338K983802LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SBMJN1999-07-30
573211775578343K981009HEARTPORT ENDOPULMONARY VENT CATHETERDWF1998-09-04
1178531775578343K981009HEARTPORT ENDOPULMONARY VENT CATHETERDWF1998-09-04
157141107755539K973201PROVI CEMENTEMA1998-06-05
573212009138894K972570HEARTPORT INTRODUCER SHEATHDYB1997-10-01
1178532009138894K972570HEARTPORT INTRODUCER SHEATHDYB1997-10-01
573211209852602K971291HEARTPORT ENDOARTERIAL RETURN CANNULADWF1997-06-17
1178531209852602K971291HEARTPORT ENDOARTERIAL RETURN CANNULADWF1997-06-17
1178531552943068K964248HEARTPORT ENDOCORONARY SINUS CATHETRDWF1997-01-22
1178531498641641K964161HEARTPORT ENDOAORTIC CLAMPDXC1997-04-04
1178532070255829K962858HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEMDXC1996-09-30
1178531569509058K962510HEARTPORT ENDOAORTIC CLAMPDXC1996-09-11
157141241330377K960938PROV-KBEBG1996-04-18
1178531627486625K960098RMI INTERNAL MAMMARY ARTERY CANNULADQR1996-03-26
573211024941791K955816VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITORDYG1997-05-06
1178531656639928K955132HEARTPORT ENDOAORTIC CLAMPDXC1996-06-07
573211399888722K951566SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]DYG1995-11-27
3477091402540327K951566SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]DYG1995-11-27
157141341190154K951075S & C VINYL POLYSILOXANE IMPRESSION MATERIALELW1995-03-31
3477091849442333K942457GRAFT THROMBECTOMY INSTRUMENTSMCW1995-02-07
573212054736679K942457GRAFT THROMBECTOMY INSTRUMENTSMCW1995-02-07
3477091230174822K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETERDYG1994-05-24
573211780527625K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETERDYG1994-05-24
573211058000586K934742SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORTDYG1994-01-24
3477091276395751K934742SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORTDYG1994-01-24
3477091802546451K926450EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATHDQE1993-02-22
573211844867035K926450EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATHDQE1993-02-22
573211268556230K926138CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RINGKRH1993-06-22
1178531268556230K926138CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RINGKRH1993-06-22
573211749391495K925638PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600DXO1993-10-18
573211701752321K924661SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETERKRA1993-04-08
3477091760674244K924661SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETERKRA1993-04-08
3477091113427413K924452SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETERDYG1993-10-29
573211496814428K924452SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETERDYG1993-10-29
573211565751356K923367COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600KRH1993-01-06
1178531565751356K923367COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600KRH1993-01-06
1178532000045439K922083RMI SURGICCAL SITE VISUALIZATION WANDFQH1993-01-29
573211442415178K915726PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATHDQO1992-09-21
3477092073667714K915726PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATHDQO1992-09-21
573211916304244K912554ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRIKRH1991-09-09
1178531916304244K912554ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRIKRH1991-09-09
573212020325373K911051MONARCH SYSTEMMHX1991-08-22
573211307835472K910221RMI VASCULAR TOURNIQUET KITDXC1991-05-16
1178531307835472K910221RMI VASCULAR TOURNIQUET KITDXC1991-05-16
3477091097746347K910204SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)DQO1991-04-24
573211923877145K910204SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)DQO1991-04-24
573211116041552K905707BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERSFGE1991-02-13
3477091748949150K905707BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERSFGE1991-02-13
3477091177215850K905458SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHERDQE1991-02-07
573211611482014K905458SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHERDQE1991-02-07
1178531332004087K905312DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELSDWF1991-01-15
1178531868364932K905311DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.DWD1991-01-15
573211437359262K901736OXIMETRY PROBE CATHETERSDQE1990-09-11
3477092031753840K901736OXIMETRY PROBE CATHETERSDQE1990-09-11
3477091584598161K901625FOGARTY ARTERIAL EMBOLECTOMY II CATHETERDXE1990-07-06
573212023807060K901625FOGARTY ARTERIAL EMBOLECTOMY II CATHETERDXE1990-07-06
1178531772485555K901231RMI CARDIOPLEGIA DELIVERY KITSDWF1990-06-08
573211200607658K896819VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONKRA1990-01-19
1178531727527985K896778RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVEDWF1990-02-27
1178531999468098K896777RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINEDWF1990-02-27
573211196364771K896466SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUMEDYG1990-02-08
3477091773021761K896466SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUMEDYG1990-02-08
573211513710871K894243RMI ARTERIAL PERFUSION CANNULADQR1989-09-19
1178531513710871K894243RMI ARTERIAL PERFUSION CANNULADQR1989-09-19
3477091068978934K892410FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETERDXE1989-07-20
573211858460119K892410FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETERDXE1989-07-20
1178531418515405K892377RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SETDTL1989-12-07
573211576100425K884329SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTERDQA1988-12-16
573211865666281K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2DXG1987-09-15
3477091216484974K864330SHEAR FORCE GAUGEDXE1987-01-06
573211698557804K864330SHEAR FORCE GAUGEDXE1987-01-06
1178531601783276K861790RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNTDWF1986-07-21
573211555903313K861322RMI POROUS VENT PLUGDWF1986-05-30
1178531555903313K861322RMI POROUS VENT PLUGDWF1986-05-30
1178531630561882K860988RMI CAROTID BY-PASS SHUNTDWF1986-05-21
1178531235482974K860497CAROTID BALLOON SHUNTDWF1986-05-28
1178531887534648K852456FAP-CATHDQO1985-11-01
573211172398633K842105RIGHT VENTRICULAR EJECTION FRACTION-DXG1985-01-15
573211349899943K833997CO-SET1984-04-17
573211102153579K833763PERICARDIAL PATCHDXZ1984-11-01
573211308823316K832554FOGARTY 6MM SOFTJAW CLIPDXC1983-09-29
3477091904290553K832554FOGARTY 6MM SOFTJAW CLIPDXC1983-09-29
1178531366433703K831759INTRACARDIA SUCKERSDWF1983-08-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWF432020-03-29
DYG382024-12-09
DYB192026-04-17
DQK182026-02-24
KRH182025-09-23
DXE182024-08-28
DQE162018-02-20
DXC152017-01-26
DXG112014-05-22
MUD92024-10-16
EBF82024-10-18
DXO82022-12-22
LDF82015-10-15
DQO82011-02-11
PLP72025-11-19
DXN72023-10-24
KRA72018-11-08
LLZ72014-10-31
NPT62015-06-17
EMA62009-09-25
DRS52025-03-21
LWR52017-06-29
MJN52015-11-23
KRB52010-12-07
DQR52008-01-31
OZT42014-10-29
QAQ32023-06-08
NKM 32022-09-14
KLE32022-07-06
LCX32022-02-18
NPV 32020-08-31
LNS32011-08-01
DTM32006-09-27
ELW32001-11-01
EJK22020-11-20
FLL22016-08-24
FMF22016-06-17
OMZ22016-01-07
KIF22013-07-24
DTL22012-01-12

NDC#

ED APAP

EDWARDS PHARMACEUTICALS, INC.

ACETAMINOPHEN

RYMED

EDWARDS PHARMACEUTICALS, INC.

DEXCHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE

UROGESIC BLUE

EDWARDS PHARMACEUTICALS, INC.

METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, and HYOSCYAMINE SULFATE

UROGESIC BLUE

EDWARDS PHARMACEUTICALS, INC.

METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, and HYOSCYAMINE SULFATE

ED A-HIST

Edwards Pharmaceuticals, Inc.

Chlorpheniramine/Phenylephrine

ED A-HIST DM

EDWARDS PHARMACEUTICALS, INC.

DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE

RYNEX PE

EDWARDS PHARMACEUTICALS, INC.

BROMPHENIRAMINE MALEATE and Phenylephrine HCL

Rynex

Edwards Pharmaceuticals, Inc

Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

RYNEX PSE

EDWARDS PHARMACEUTICALS, INC.

BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE

ED BRON GP

EDWARDS PHARMACEUTICALS, INC.

GUAIFENESIN and PHENYLEPHRINE

ED-A-HIST DM

EDWARDS PHARMACEUTICALS, INC.

CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

ED A-HIST

EDWARDS PHARMACEUTICALS, INC.

CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE

Etodolac

Edenbridge Pharmaceuticals LLC.

Etodolac

Etodolac

Edenbridge Pharmaceuticals LLC.

Etodolac

Bumetanide

Edenbridge Pharmaceuticals LLC.

Bumetanide

Bumetanide

Edenbridge Pharmaceuticals LLC.

Bumetanide

Bumetanide

Edenbridge Pharmaceuticals LLC.

Bumetanide

Carbidopa

Edenbridge Pharmaceuticals LLC.

Carbidopa

Tinidazole

Edenbridge Pharmaceuticals LLC.

Tinidazole

Tinidazole

Edenbridge Pharmaceuticals LLC.

Tinidazole

Yargesa

Edenbridge Pharmaceuticals LLC.

Miglustat

Ivermectin

Edenbridge Pharmaceuticals LLC.

Ivermectin

Vigabatrin

Edenbridge Pharmaceuticals LLC.

Vigabatrin

199 records. Showing 1-40. Next

PMA#

Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

2023-01-20

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS151 Date Received01/05/2023 Decision Date01/20/2023 Product Code NPT  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement ...

PASCAL Precision Transcatheter Valve Repair System

2022-12-20

Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS005 Date Received12/19/2022 Decision Date12/20/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

Crimper

2022-12-12

Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS032 Date Received11/14/2022 Decision Date12/12/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chang...

Crimper

2022-12-12

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS150 Date Received11/14/2022 Decision Date12/12/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

PASCAL Precision Transcatheter Valve Repair System

2022-12-07

Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS003 Date Received11/07/2022 Decision Date12/07/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

PASCAL Precision Transcatheter Valve Repair System

2022-12-07

Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS004 Date Received11/15/2022 Decision Date12/07/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

PASCAL Precision Transcatheter Valve Repair System

2022-11-20

Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS002 Date Received10/18/2022 Decision Date11/20/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change...

Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories

2022-11-16

Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS031 Date Received10/25/2022 Decision Date11/16/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chang...

Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories

2022-11-16

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS149 Date Received10/25/2022 Decision Date11/16/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

Edwards Certitude Introducer Sheath Set

2022-10-26

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS147 Date Received09/26/2022 Decision Date10/26/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

Edwards Commander Delivery System

2022-10-24

Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS030 Date Received10/04/2022 Decision Date10/24/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chang...

Edwards Commander Delivery System

2022-10-24

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS148 Date Received10/04/2022 Decision Date10/24/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

EDWARDS INTUITY Elite Valve System

2022-10-19

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS065 Date Received10/12/2022 Decision Date10/19/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) System

2022-09-23

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS145 Date Received08/25/2022 Decision Date09/23/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement ...

EDWARDS INTUITY Elite Valve System

2022-09-23

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS064 Date Received08/25/2022 Decision Date09/23/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

Edwards SAPIEN 3™ Transcatheter Heart Valve

2022-09-23

Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS027 Date Received08/25/2022 Decision Date09/23/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chang...

PASCAL Precision Transcatheter Valve Repair System

2022-09-14

Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Date Received03/14/2022 Decision Date09/14/2022 Product Code NKM  Advisory Committee Cardiovascular Clinical TrialsNCT03706833 Expedited Review Granted? No

Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses

2022-09-12

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP860057 Supplement NumberS208 Date Received08/15/2022 Decision Date09/12/2022 Product Code DYE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

Edwards INTUITY Elite Valve System

2022-09-12

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS063 Date Received08/15/2022 Decision Date09/12/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

2022-07-28

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP140031 Supplement NumberS141 Date Received05/02/2022 Decision Date07/28/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Chang...

Edwards SAPIEN 3 Pulmonic Delivery System

2022-07-25

Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS023 Date Received06/30/2022 Decision Date07/25/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chang...

Edwards Alterra Adaptive Prestent System

2022-07-06

Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS022 Date Received06/06/2022 Decision Date07/06/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chang...

Edwards INTUITY ELITE Delivery System

2022-04-20

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS062 Date Received03/22/2022 Decision Date04/20/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

KONECT RESILIA Aortic Valved Conduit

2022-04-08

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS063 Date Received04/06/2022 Decision Date04/08/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

Edwards Alterra Adaptive Prestent System

2022-04-08

Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS019 Date Received04/04/2022 Decision Date04/08/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chang...

EDWARDS INTUITY Elite Valve

2022-03-31

EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS060 Date Received03/08/2022 Decision Date03/31/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

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