Product code DTE
- Device name
- Pulse-Generator, Pacemaker, External
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.3600
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P920032S008 | MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER | Pace Medical | 2002-02-20 |
| P920032S007 | BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170 | Pace Medical | 2001-10-26 |
| P920032S006 | MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER | Pace Medical | 2001-04-06 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241781 | Solo Pace Control | Solo Pace, Inc. | 2025-01-10 |
| K232721 | Lifetech Cardio Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2024-01-07 |
| K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2020-05-13 |
| K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2019-04-30 |
| K182839 | Lifetech Cardio Model 8301 Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2019-02-28 |
| K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2018-08-21 |
| K180873 | Medtronic Model 53401 External Pulse Generator (EPG) | Medtronic, Inc. | 2018-04-19 |
| K162054 | Medtronic Temporary External Pacemaker 53401 | Medtronic, Inc. | 2016-10-18 |
| K162550 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2016-10-12 |
| K150246 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2015-02-18 |
| K132924 | MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) | Medtronic, Inc. | 2013-10-31 |
| K123916 | PSA SERIES | Osypka Medical, Inc. | 2013-04-09 |
| K042708 | ERA 3000 PACING SYSTEM ANALYZER | Biotronik, Inc. | 2004-10-20 |
| K033130 | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR | Osypka Medical, Inc. | 2003-10-31 |
| K023080 | GALIX PACESTAR | Galix Biomedical Instrumentation, Inc. | 2003-06-11 |
| K022939 | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES | Osypka Medical, Inc. | 2002-10-03 |
| K020896 | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE | Osypka Medical, Inc. | 2002-06-14 |
| K011980 | ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 | Pace Medical | 2001-09-12 |
| K002204 | PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V | Pace Medical | 2000-10-18 |
| K001180 | TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 | Pace Medical | 2000-06-27 |
| K970347 | MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM | Paladin Medical, Inc. | 1997-08-29 |
| K971474 | MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL | Medtronic Vascular | 1997-07-14 |
| K964190 | ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | Biotronik, Inc. | 1997-07-10 |
| K970497 | PACE 101H | Sulzer Oscor, Inc. | 1997-06-04 |
| K960676 | ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004 | Zoll Medical Corp | 1996-06-05 |
| K940467 | REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 | Remington Medical, Inc. | 1994-11-01 |
| K934016 | POWERCHARGER | Zoll Medical Corp | 1994-10-18 |
| K925143 | MODEL 4800 ACCUPACE PACING SYSTEM ANALYER | Pace Medical | 1994-09-27 |
| K923621 | EXTERNAL DEMAND PACEMAKER | Oscor Medical Corp. | 1993-05-19 |
| K923398 | CPI MODEL 2215 | Seamed Corp. | 1992-08-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850056280020 | SoloPace EPG | SOLO PACE INC. | 2026-02-02 |
| 00850056280013 | Solo Pace Control System | SOLO PACE INC. | 2025-01-23 |
| 00850056280037 | Solo Pace Control System | SOLO PACE INC. | 2025-01-23 |
| 04260451441173 | Osypka Medical | Osypka Medical GmbH | 2021-04-30 |
| 04260451441067 | CARDIOTRONIC | Osypka Medical GmbH | 2021-04-30 |
| 04260451441050 | CARDIOTRONIC | Osypka Medical GmbH | 2021-04-30 |
| 00763000162443 | NA | MEDTRONIC, INC. | 2018-11-11 |
| 00643169723160 | NA | MEDTRONIC, INC. | 2017-03-12 |
| 00643169725126 | NA | MEDTRONIC, INC. | 2017-01-29 |
| 00847946021986 | HWD Electrode Set | Zoll Medical Corporation | 2016-10-20 |
| 00885672005467 | PACE 203H | Oscor Inc. | 2016-09-17 |
| 04260451441012 | CARDIOTRONIC | Osypka Medical GmbH | 2016-09-13 |
| 04260451441029 | CARDIOTRONIC | Osypka Medical GmbH | 2016-09-13 |
| 00836559008859 | PACE 101H | Oscor Inc. | 2016-09-09 |
| 00836559008866 | PACE 203H | Oscor Inc. | 2016-09-09 |
| 00643169382978 | 5391 | Oscor Inc. | 2016-09-09 |
| 00847946021191 | PRO PADZ | Zoll Medical Corporation | 2016-08-03 |
| 00847946016661 | PRO PADZ | Zoll Medical Corporation | 2015-10-21 |
| 00643169508767 | NA | MEDTRONIC, INC. | 2014-11-13 |
| 00847946016401 | PRO PADZ | Zoll Medical Corporation | 2014-09-24 |
| 00847946016463 | PRO PADZ | Zoll Medical Corporation | 2014-09-24 |
| 00643169230859 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 00643169305120 | NA | MEDTRONIC, INC. | 2014-09-23 |
| 04035479010355 | PK-67-L/2,6m | BIOTRONIK SE & Co. KG | 2014-08-20 |
| 04035479015473 | PK-67-S/0,8m | BIOTRONIK SE & Co. KG | 2014-08-20 |
| 04035479049300 | PK-175/2,3m | BIOTRONIK SE & Co. KG | 2014-08-19 |
| 04035479079581 | PK-83-B/2,5m | BIOTRONIK SE & Co. KG | 2014-08-19 |
| 04035479080228 | PK-83-B/1,5m | BIOTRONIK SE & Co. KG | 2014-08-19 |