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Medtronic Heart Valves Division

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20255872025587Medtronic Heart Valves Division1N2026-01-011851 EAST DEERE AVE. Santa Ana CA US 92705

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
58211512206475P990064MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVEDYE2000-07-14
58211242148943P990046ATS OPEN PIVOT BILEAFLET HEART VALVELWQ2000-10-13
58211092786922P980043HANCOCK II PORCINE BIOPROSTHESISDYE1999-09-28
58211180504177P970031MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESISLWR1997-11-26
58211126182353P870078HANCOCK PORCINE BIOPROSTHESISDYE1989-09-28
58211974486763P790007HANCOCK MODIFIED ORIFICE BIOPROSTHESISLWR1979-11-15
58211091031584P200046Harmony™ TPV SystemNPV2021-03-26
58211544873900P170006AVALUS(TM) BIOPROSTHESISLWR2017-07-31
58211150969043P140017MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)NPV2015-01-27
58211343864551P130021MEDTRONIC COREVALVE SYSTEMNPT2014-01-17
58211500600630P060025ATS 3F AORTIC BIOPROSTHESISLWR2008-10-30
58211086761684K960356POSTERIOR ANNULOPLASTY BAND (MODEL 607)KRH1996-08-27
58211931155936K250075Medtronic Stedi Extra Support GuidewireDQX2025-06-13
58211439011614K201449SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty RingKRH2020-07-01
58212006680668K190716Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing LeadLDF2019-08-08
58211151957657K181132Tri-Ad 2.0 Adams Tricuspid BandKRH2018-05-29
58211549263245K181001Medtronic Confida Brecker GuidewireDQX2018-05-03
58211626645316K171253Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing LeadLDF2017-05-25
58211576982904K161249Streamline 6495 Bipolar Temporary Myocardial Pacing LeadLDF2016-08-19
58211478114587K150465Medtronic Confida Brecker GuidewireDQX2015-08-03
58211346655005K140972UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACINGLDF2014-06-06
58211813028833K132623MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIREDQX2013-12-19
58211074506028K101212MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690RKRH2010-08-07
58212009443208K093903ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFCKRH2010-07-15
58211523978220K090721CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205OCL2009-06-16
58211258622627K090428ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 ACKRH2009-05-07
58211407140138K083683ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SCKRH2009-02-25
58211862738252K073324MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680RKRH2008-03-13
58211357885630K072655ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SRKRH2007-10-23
58211294594876K071214ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RINGKRH2007-07-31
58212019345525K061127CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638RKRH2006-05-23
58211590255491K052970SIMPLICI-T ANNULOPLASTY SYSTEMKRH2006-01-11
58211851751160K052899ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FCKRH2005-11-17
58211501022155K052860CG FUTURE ANNULOPLASTY BANDKRH2005-11-10
58211101019147K052565ATS SIMULUS ANNULOPLASTY RING, MODEL 700FFKRH2005-11-17
58211462184681K032810DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCOREKRH2003-12-05
58211002511704K012460MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEADLDF2001-08-14
58211541884038K012459MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRELDF2001-08-14
58211997256456K012458MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEADLDF2001-08-14
58211263986609K012454MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEADLDF2001-08-14
58211394654529K012452MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEADLDF2001-08-14
58211163058984H080002
58211924324604H020003
58211068595650
58211878348780
58211958828086
58211438682431
58211519817779
58211628872430

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KRH162020-07-01
LDF102019-08-08
DQX42025-06-13
LWR42017-07-31
DYE32000-07-14
NPV22015-01-27
NPV 12021-03-26
NPT12014-01-17
OCL12009-06-16
LWQ12000-10-13