ClearanceBrief
Panels › Cardiovascular › Product code DXY · Class 3

Implantable Pacemaker Pulse-Generator

Regulation 870.3610

0510(k)s in 12 months (461 all time)
0recalls in 12 months (75 all time)
1recalls that name a 510(k)
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Top companies in DXY

DateFirm and productCodeLinked 510(k)
Jun 17, 2022St. Jude Medical, Cardiac Rhythm Management Division
Merlin.net model MN5000 Software
Open, Classified
DXYNone listed
Jun 17, 2022St. Jude Medical, Cardiac Rhythm Management Division
Merlin 2 PCS MER37000 programmer Model MER3400 software
Open, Classified
DXYNone listed
Jun 17, 2022St. Jude Medical, Cardiac Rhythm Management Division
Merlin PCS 3650 programmer Model 3330 software
Open, Classified
DXYNone listed
Aug 28, 2017St Jude Medical Inc.
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that pr
Terminated
DXYNone listed
Aug 28, 2017St Jude Medical Inc.
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power s
Terminated
DXYNone listed
Aug 28, 2017St Jude Medical Inc.
Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: S
Terminated
DXYNone listed
Aug 28, 2017St Jude Medical Inc.
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single
Terminated
DXYNone listed
Jan 11, 2012St Jude Medical CRMD
Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
Terminated
DXYNone listed
Jan 11, 2012St Jude Medical CRMD
Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
Terminated
DXYNone listed
Apr 26, 2010Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial ta
Terminated
DXYNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker, model SVVI103, for ventricular use only.
Terminated
DXYNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber atrial sensing, ventricular sensing and pacing Pacemaker, model SVDD303.
Terminated
DXYNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Rate Responsive Pacemaker, models DR353, SDR203, SDR303, and SDR306.
Terminated
DXYNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Pacemaker, models SD203 and SD303.
Terminated
DXYNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Rate Responsive Pacemaker; models SR353, SSR203, SSR303, and SSR306.
Terminated
DXYNone listed
Jun 11, 2009Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker; models SS103, SS106, SS203, and SS303.
Terminated
DXYNone listed
Dec 19, 2006St Jude Medical CRMD
St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
Terminated
DXYNone listed
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only.
Terminated
DXYNone listed
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Rate Responsive Pacemaker, models SSR203, SSR303, SSR306
Terminated
DXYNone listed
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303
Terminated
DXYNone listed
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303.
Terminated
DXYNone listed
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306
Terminated
DXYNone listed
Feb 18, 2006Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303
Terminated
DXYNone listed
Dec 2, 2005ela Medical Llc
ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical,
Terminated
DXYNone listed
Dec 2, 2005ela Medical Llc
Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. S
Terminated
DXYNone listed
Nov 23, 2005Guidant Corporation
Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers
Terminated
DXYNone listed
Nov 23, 2005Guidant Corporation
Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) a
Terminated
DXYNone listed
Nov 23, 2005Guidant Corporation
Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390)
Terminated
DXYNone listed
Nov 23, 2005Guidant Corporation
Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics N
Terminated
DXYNone listed
Sep 24, 2005Guidant Corporation
Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemake
Terminated
DXYNone listed
Sep 24, 2005Guidant Corporation
Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (models1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 13
Terminated
DXYNone listed
Sep 24, 2005Guidant Corporation
Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model
Terminated
DXYNone listed
Sep 24, 2005Guidant Corporation
Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedi
Terminated
DXYNone listed
Sep 13, 2005Scanlan International Inc
SCANLAN Premier Jacobson Micro Scissors, spring style, round handle, V-neck, 125-degree angled nano blades, 6-1/2'', 16.5 cm. Catalog no. 7007-598.
Terminated
DXYNone listed
Sep 13, 2005Scanlan International Inc
SCANLAN Premier Jacobson Micro Scissors, spring style, round handle, 90-degree angled nano blades, 6-12'', 16.5 cm. Catalog no. 7007-596.
Terminated
DXYNone listed
Sep 13, 2005Scanlan International Inc
SCANLAN Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled nano blades, 6-1/8'', 15.5 cm. Catalog no. 7007-548.
Terminated
DXYNone listed
Sep 13, 2005Scanlan International Inc
SCANLAN Premier Jacobson Micro Scissors, spring style, round handle, V-neck, 125-degree angled micro fine blades, 8'', 20 cm. Catalog no. 7007-499-8
Terminated
DXYNone listed
Sep 13, 2005Scanlan International Inc
SCANLAN Premier Jacobson Micro Scissors, Spring Style, round handle, V-neck, 125-degree angled micro fine blades, 6-1/2'', 16.5 cm. Catalog no. 7007-499.
Terminated
DXYNone listed
Sep 13, 2005Scanlan International Inc
Scanlan Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled micro fine blades, 8'', 20 cm. Catalog Number 7007-449-8.
Terminated
DXYNone listed
Sep 13, 2005Scanlan International Inc
Scanlan Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled micro fine blades, 6-1/4'', 16 cm. Catalog Number 7007-449.
Terminated
DXYNone listed
Oct 24, 2003St Jude Medical
Pulse Generator
Terminated
DXYNone listed
Jul 15, 2003Guidant Corp-Cpi Division
Pulsar Max II Multiprogrammable Pacemaker, Model 1280
Terminated
DXYNone listed
Jul 15, 2003Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 1286
Terminated
DXYNone listed
Jul 15, 2003Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 1284
Terminated
DXYNone listed
Jul 15, 2003Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 1283
Terminated
DXYNone listed
Jul 15, 2003Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 1184
Terminated
DXYNone listed
Jul 15, 2003Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 0981
Terminated
DXYNone listed
Jul 15, 2003Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 0481
Terminated
DXYNone listed
Jul 15, 2003Guidant Corp-Cpi Division
Pulsar Max II Multiprogrammable Pacemaker, Model 1181
Terminated
DXYNone listed
Jul 15, 2003Guidant Corp-Cpi Division
Pulsar Max II Multiprogrammable Pacemaker, Model 1180
Terminated
DXYNone listed

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