Product Code: DXY


Products Classified as DXY

830Implantable Pacemaker Pulse-generatorImplantable Pacemaker Pulse Generator.

Total Product Life Cycle (TPLC) Devices

830Implantable Pacemaker Pulse-generatorImplantable Pacemaker Pulse Generator.

FDA Consensus Standards

Implantable Pacemaker Pulse-Generator [36797]21 CFR §870.3610 🔎
Implantable Pacemaker Pulse-Generator [37688]21 CFR §870.3610 🔎

Pre-market Approvals for DXY

P870054KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATORCOOK PACEMAKER CORP.
P890003MEDTRONIC(R) MODEL 9870A SOFTWARE DISKETTESMedtronic, Inc.
P960004THINLINE ENDOCARDIAL PACING LEADSBOSTON SCIENTIFIC
P900070META DDDR MODEL 1256 PULSE GENERATORST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
P970012KAPPA 400 PACEMAKER FAMILYMEDTRONIC Inc.
P980035MEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELSMEDTRONIC Inc.
P910023CADENCE (R) TIERED THERAPY DEFIBRILLATOR SYSTEMSt. Jude Medical
P980049Platinum VR/DR ICDS,Paradym RF VR/ RF DR CRT-Ds, Intensia VR, Intensia DRMicroPort CRM USA Inc.
P060027Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-DsMicroPort CRM USA Inc.
P950029REPLY & ESPRIT SR & DR PacemakersMicroPort CRM USA Inc.
P950037Evia DR/SR; Evia DR-T/SR-T; Entovis DR/SR, Entovis DR-T/SR-T; Estella DR/SR; Estella DR-T/SR-T; Effecta D/S; Edora 8 DR/BIOTRONIK, INC.
P140033Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)St. Jude Medical, Inc.
P880086Assurity, Assurity+, Endurity, Accent family of PacemakersSt. Jude Medical, Inc.
P940031Accessory KitBOSTON SCIENTIFIC

Pre-market Notifications for DXY

K993434PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-ABIOTRONIK, INC.
K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSELA MEDICAL, INC.
K953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSCOOK PACEMAKER CORP.
K952328NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01BIOTRONIK, INC.
K952364OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)ELA MEDICAL, INC.
K950210CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKERCARDIAC CONTROL SYSTEMS, INC.
K946188CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKERCARDIAC CONTROL SYSTEMS, INC.
K945627PIKOS LP 01, PIKOS LP E01BIOTRONIK, INC.
K941937PIKOS E 01-BBIOTRONIK, INC.
K923868CCS MAESTRO II SERIES 200 CARDIAC PACEMAKERCARDIAC CONTROL SYSTEMS, INC.
K923026PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKERBIOTRONIK, GMBH & CO.
K920601ASTRA T2, ASTRA T4, ASTRA T6CARDIAC PACEMAKERS, INC.
K920530INTERMEDICS MODEL 366-15 VS 1 HEADER PLUGINTERMEDICS, INC.
K920157SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETERSCHNEIDER INTL., LTD.
K914109PIKOS 01 & PIKOS E 01BIOTRONIK, GMBH & CO.

Global Unique Device Identification Database

00613994909688implantable pacemaker Pulse-generator
00613994618160implantable pacemaker Pulse-generator
00613994501035implantable pacemaker Pulse-generator
00613994501011implantable pacemaker Pulse-generator
00643169838604implantable pacemaker Pulse-generator
00643169431874implantable pacemaker Pulse-generator
00643169431850implantable pacemaker Pulse-generator
00643169369030implantable pacemaker Pulse-generator
00681490199285implantable pacemaker Pulse-generator
00681490132558implantable pacemaker Pulse-generator
00721902438400implantable pacemaker Pulse-generator
00721902309564implantable pacemaker Pulse-generator
00721902307317implantable pacemaker Pulse-generator
00721902307300implantable pacemaker Pulse-generator
05414734010474implantable pacemaker Pulse-generator

Maude Adverse Events

MEDTRONIC ICDMEDTRONIC, INC.2020-03-31
VITATRON G SERIES SRMEDTRONIC EUROPE SARL2020-03-31
MEDTRONIC LEADMEDTRONIC, INC.2020-03-31
MEDTRONIC LEADMEDTRONIC, INC.2020-03-31
MEDTRONIC LEADMEDTRONIC, INC.2020-03-31
CAPSURE VDD-2 LEADMPRI2020-03-31
5356 VERITY DR, AB 20 55 184ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-30
REPLYSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-30
IDENTITY ADX XLABBOTT2020-03-27
VICTORY XL DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-27
MEDTRONIC LEADMEDTRONIC, INC.2020-03-27
VERITY ADX SRST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-27
IDENTITY ADX XL DRABBOTT2020-03-27
MEDTRONIC LEADMEDTRONIC, INC.2020-03-26
VERITY ADX SRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-24
IDENTITY ADX XL DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-24
VERITY ADX XL VDRABBOTT2020-03-24
AV PLUS DX BIFUR BIPOLAR LEADST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-23
REPLYSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-23
VICTORY XL DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-23
VICTORY XL DRST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-22
REPLYSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-21
MEDTRONIC LEADMEDTRONIC, INC.2020-03-20
REPLYSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-20
MEDTRONIC LEADMEDTRONIC, INC.2020-03-19
IDENTITY ADX XL DRST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-17
MEDTRONIC LEADMEDTRONIC, INC.2020-03-17
IMPLANTABLE PACEMAKER PULSE-GENERATORBOSTON SCIENTIFIC CORPORATION2020-03-17
REPLYSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-17
REPLYSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-17
REPLYSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-17
MEDTRONIC LEADMEDTRONIC, INC.2020-03-16
MEDTRONIC ICDMEDTRONIC, INC.2020-03-16
MEDTRONIC LEADMEDTRONIC, INC.2020-03-13
MEDTRONIC LEADMEDTRONIC, INC.2020-03-13
REPLYSORIN GROUP ITALIA S.R.L. - CRM FACILITY2020-03-13
MEDTRONIC LEADMEDTRONIC, INC.2020-03-13
VITATRON A-SERIES IMPLANTABLE PACEMAKERSMEDTRONIC SINGAPORE OPERATIONS2020-03-13
VITATRON A-SERIES IMPLANTABLE PACEMAKERSMEDTRONIC SINGAPORE OPERATIONS2020-03-13
CAPSURE VDD-2 LEADMPRI2020-03-13
MEDTRONIC LEADMEDTRONIC, INC.2020-03-11
ENDURITYABBOTT2020-03-11
MEDTRONIC LEADMEDTRONIC, INC.2020-03-11
VICTORY XL DRST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-11
VICTORY XL DRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-11
IDENTITY ADX XLST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-10
5366, INTEGRITY DR, AB 20 73 559ST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-10
VICTORY XL DRABBOTT2020-03-10
MEDTRONIC LEADMEDTRONIC, INC.2020-03-10
VICTORY XL DRABBOTT2020-03-09

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