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Medtronic, Inc.

6,204 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
CoreValve, Evolut-R Evolut PRO (P130021/S045)Medtronic, Inc.2017-11-16
Consulta CRT-P, Percepta Bipolar CRT-P / Percepta Quadripolar CRT-P, Serena Bipolar CRT-P / Serena Quadripolar CRT-P, So (P010015/S345)Medtronic, Inc.2017-11-13
Revo MRI SureScan IPG (P090013/S264)Medtronic, Inc.2017-11-13
Advisa DR IPG / DR MRI IPG/ SR MRI IPG; Astra XT DR MRI IPG / S DR MRI IPG / S SR MRI IPG/ XT SR MRI IPG; AZURA S DR MRI (P980035/S523)Medtronic, Inc.2017-11-13
Medtronic Attain Ability Model 4196 (P080006/S114)Medtronic, Inc.2017-11-09
CapSure Epicardial Pacing Lead (P950024/S076)Medtronic, Inc.2017-11-09
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S177)Medtronic, Inc.2017-11-09
CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S382)Medtronic, Inc.2017-11-09
Activa Deep Brain Stimulation Therapy System (P960009/S299)Medtronic, Inc.2017-11-03
Attesta DR MRI SureScan, L DR MRI SureScan, S DR MRI SureScan, SR MRI SureScan, Sphera DR MRI SureScan, L DR MRI SureSca (P980035/S522)Medtronic, Inc.2017-10-31
Activa Deep Brain Stimulation Therapy System (P960009/S291)Medtronic, Inc.2017-10-26
CapSure Fix Novus Lead (4076, 5076) (P930039/S176)Medtronic, Inc.2017-10-24
CRTP-Quad: Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bi (P010015/S344)Medtronic, Inc.2017-10-24
Orion: Astra XT DR MIR IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, AZURE S DR MRI IPG, AZURE S SR (P980035/S521)Medtronic, Inc.2017-10-24
Activa Deep Brain Stimulation Therapy System (P960009/S297)Medtronic, Inc.2017-10-20
Percepta Quad CRT-P MRI SureScan / Percepta CRT-P MRI SureScan / Serena Quad CRT-P MRI SureScan / Splar Quad CRT-P MRI S (P010015/S340)Medtronic, Inc.2017-10-19
MyCareLink Patient Monitor, Device Command Library (DCL) , Device Data Management Application (DDMA) CareLink Express, C (P890003/S378)Medtronic, Inc.2017-10-19
Activa Deep Brain Stimulation Therapy System (P960009/S298)Medtronic, Inc.2017-10-18
MINIMED 530G SYSTEM (P120010/S101)Medtronic, Inc.2017-10-11
Activa Deep Brain Stimulation Therapy System (P960009/S296)Medtronic, Inc.2017-10-06
SyncroMed Infusion System, Ascenda Intrathecal Catheter Product Code:LKK (P860004/S271)Medtronic, Inc.2017-10-06
Azure XT DR/SR Mri SureScan IPG; Azure S DR/SR MRI Sure Scan IPG (P980035/S520)Medtronic, Inc.2017-10-05
Hancock Valved Conduit (P870078/S038)Medtronic, Inc.2017-10-03
Hancock II and Hancock Ultra II Bioprosthesis (P980043/S063)Medtronic, Inc.2017-10-03
Melody Transcatheter Pulmonary Valve (TPV) (P140017/S008)Medtronic, Inc.2017-10-03
Freestyle Bioprosthesis (P970031/S059)Medtronic, Inc.2017-10-03
Mosaic Bioprosthesis & Mosaic Ultra Bioprosthesis (P990064/S071)Medtronic, Inc.2017-10-03
Evolut R Transcatheter Aortic Valve (TAV) (P130021/S042)Medtronic, Inc.2017-10-03
SynchroMed Infusion System (P860004/S284)Medtronic, Inc.2017-09-26
Activa Deep Brain Stimulation Therapy System (P960009/S286)Medtronic, Inc.2017-09-26
Attain Performa Lead Models 4298, 4398, 4598 (P080006/S115)Medtronic, Inc.2017-09-22
Activa Deep Brain Stimulation Therapy System (P960009/S295)Medtronic, Inc.2017-09-19
OUS Vitatron Application Software (P890003/S377)Medtronic, Inc.2017-09-11
HV splitter/adaptor kit 5019 (P920015/S202)Medtronic, Inc.2017-09-05
EVERA MRI DF-1/ DF-1 ICD/MRI ICD/ EVERA XT DR ICD/ VR ICD; PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR ICD; VISIA AF (P980016/S616)Medtronic, Inc.2017-09-01
AMPLIA MRI CRT-D /QUAD CRT-D; CLARIA MRI CRT-D/QUAD CRT-D; COMPIA MRI CRT-D /QUAD CRT-D; CONCERTO ICD & II CRT-D; CONSUL (P010031/S575)Medtronic, Inc.2017-09-01
Activa Deep Brain Stimulation Therapy System (P960009/S289)Medtronic, Inc.2017-09-01
SYNERGYST II PULSE GENERATOR (P890003/S372)Medtronic, Inc.2017-09-01
Activa Deep Brain Stimulation Therapy System (P960009/S284)Medtronic, Inc.2017-09-01
CONSULTA CRT-P & VIVA CRT-P (P010015/S318)Medtronic, Inc.2017-09-01
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S288)Medtronic, Inc.2017-08-31
En Veo R Delivery Catheter System (P130021/S040)Medtronic, Inc.2017-08-31
Percepta, Serena, Solara Bipolar/Quadripolar CRT-P (P010015/S338)Medtronic, Inc.2017-08-29
ASTRA XT DR/SR/MRI/IPG (P980035/S513)Medtronic, Inc.2017-08-29
Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Serena Quadripolar CRT-P (P010015/S341)Medtronic, Inc.2017-08-25
ASTRA S DR MRI IPG X3DR01; ASTRA S SR MRI IPG X3SR01; ASTRA XT DR MRI IPG X1DR01; ASTRA XT SR MRI IPG X1SR01 (P980035/S517)Medtronic, Inc.2017-08-25
SynchroMEd Infusion System (P860004/S287)Medtronic, Inc.2017-08-24
Activa Deep Brain Stimulation Therapy System (P960009/S288)Medtronic, Inc.2017-08-24
Activa Deep Brain Stimulation Therapy System (P960009/S290)Medtronic, Inc.2017-08-24
Micra Transcatheter Pacing System (P150033/S026)Medtronic, Inc.2017-08-18
Percepta Bipolar CRT-P/ Percepta Quadripolar CRT-P/ Serena Bipolar CRT-P/ Serena Quadripolar CRT-P/ Solar Bipolar CRT-P/ (P010015/S339)Medtronic, Inc.2017-08-17
IN.PACT Admiral Paclitaxel-Coated Balloon Catheter (P140010/S036)Medtronic, Inc.2017-08-17
ASTRA S DR MRI IPG/ ASTRA S SR MRI IPG / ASTRA XT DR MRI IPG / ASTRA XT SR MRI IPG (P980035/S515)Medtronic, Inc.2017-08-17
SynchroMed Infusion System (P860004/S283)Medtronic, Inc.2017-08-16
Attain StarFix Lead (P060039/S081)Medtronic, Inc.2017-08-16
CapSureFix Novus MRI SureScan Lead (P930039/S170)Medtronic, Inc.2017-08-16
Activa Deep Brain Stimulation Therapy System (P960009/S285)Medtronic, Inc.2017-08-16
Azure XT SR / DR MRI SureScan, Azure S SR / S DR MRI SureScan , Software Model (P980035/S506)Medtronic, Inc.2017-08-16
CapSureFix MRI Lead (P090013/S262)Medtronic, Inc.2017-08-16
MINIMED 530G SYSTEM ENLITE SENSOR (P120010/S105)Medtronic, Inc.2017-08-16
Y Adaptor/Extender Kit/Sprint Quattro Lead/Subcutaneous Lead (P920015/S201)Medtronic, Inc.2017-08-16
SynchroMed Infusion System (P860004/S286)Medtronic, Inc.2017-08-16
Attain OTW LV Lead (P010015/S342)Medtronic, Inc.2017-08-16
CapSureFix Lead/CapSureFix Novus Lead/Vitatron Crystalline Active Fixation Lead (P930039/S175)Medtronic, Inc.2017-08-16
CapSure Sense MRI SureScan Lead (P830061/S145)Medtronic, Inc.2017-08-16
CapSure Epicardial Pacing Lead (P950024/S075)Medtronic, Inc.2017-08-16
Attain Ability Lead (P080006/S113)Medtronic, Inc.2017-08-16
Myocardial Pacing Lead (P120017/S010)Medtronic, Inc.2017-08-16
Device Command Library (DCL), CareLine Express (P890003/S374)Medtronic, Inc.2017-08-16
CapSure VDD 2 Lead/Vitatron Brilliant S+ VDD Lead (P890003/S379)Medtronic, Inc.2017-08-16
CapSureFix MRI SureScan Lead (P090013/S256)Medtronic, Inc.2017-08-16
Adapta, Versa, Sensia IPGs ADSR01, ADDR01, ADDR06, ADDRL1, ADDRS1, VEDR01, ADD01, SEDRL1, SED01, SES01, ADDR03, SEDR01, (P980035/S516)Medtronic, Inc.2017-08-14
Adapta, Versa, Sensia IPG, Relia IPG (P980035/S514)Medtronic, Inc.2017-08-10
Mosaic Bioprosthesis, Models 305 and 310 (P990064/S069)Medtronic, Inc.2017-08-09
Hancock II Bioprosthesis, Models T505 and T510 (P980043/S061)Medtronic, Inc.2017-08-09
Freestyle Bioprosthesis, Model 995, 995SC and 995MS (P970031/S057)Medtronic, Inc.2017-08-09
Hancock Valved Conduit, Model 105 (P870078/S036)Medtronic, Inc.2017-08-09
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S285)Medtronic, Inc.2017-08-08
Activa Deep Brain Stimulation Therapy System (P960009/S287)Medtronic, Inc.2017-08-08
CapSureFix Novus MRI SureScan Lead (P930039/S169)Medtronic, Inc.2017-08-03
CapSureFix Novus MRI SureScan Lead (P090013/S254)Medtronic, Inc.2017-08-03
CapSureFix Novus MRI SureScan Lead (4074 and 4574) (P830061/S144)Medtronic, Inc.2017-08-03
Attesta DR MRI SureScan (P980035/S495)Medtronic, Inc.2017-08-03
AVALUS(TM) BIOPROSTHESIS (P170006)Medtronic, Inc.2017-07-31
IN.PACT Admiral Paclitaxel-Coated Balloon Catheter (P140010/S035)Medtronic, Inc.2017-07-28
Percepta/ Serena / Solara Bipolar, Quadripolar CRT-P (P010015/S337)Medtronic, Inc.2017-07-26
Attain Ability Leads 4196, 4296, 4396 (P080006/S111)Medtronic, Inc.2017-07-26
Medtronic(R) Synchromed(TM) Pump & Infusion System (P860004/S282)Medtronic, Inc.2017-07-26
ASTRA S DR/ XT DR /SR MRI IPG (P980035/S512)Medtronic, Inc.2017-07-26
Attain StarFix Lead 4195 (P060039/S080)Medtronic, Inc.2017-07-26
CapSureFix MRI Lead (P090013/S260)Medtronic, Inc.2017-07-18
Attain StarFix Lead (P060039/S079)Medtronic, Inc.2017-07-18
CapSure VDD 2 Lead/ Vitron Brilliant S+VDD Lead (P890003/S375)Medtronic, Inc.2017-07-18
Micra TPS (P150033/S025)Medtronic, Inc.2017-07-18
Attain Ability Lead; Attain Performa Lead (P080006/S110)Medtronic, Inc.2017-07-18
Sprint Quattro Lead/ Subcutanious Lead/ Transvene CS.SVC Lead (P920015/S199)Medtronic, Inc.2017-07-18
Adapta, Versa, Sensia IPG, Advisa DR,MRI,SR IPG, Astra S DR, S SR, XT DR, XT SR IPG, Relia IPG (P980035/S511)Medtronic, Inc.2017-07-18
CapSureFix Lead/ CapSureFix Novus Lead/ Vitatron Crystalline Active Fixation Lead (P930039/S173)Medtronic, Inc.2017-07-18
Revo MRI SureScan IPG (P090013/S261)Medtronic, Inc.2017-07-18
Consulta, Percept Bipolar, Percepta Quadripolar, Serena Bipolar/Quadripolar, Syncra, Viva CRT-P (P010015/S336)Medtronic, Inc.2017-07-18
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