FDA.reportPublic FDA data

External pacemaker, epicardial pacing

Definition
An external pulse generator (EPG) designed to generate periodic electrical cardiac pacing impulses and transmits them to the heart via invasive (percutaneous) leads to stimulate the heart when the sino-atrial (SA) node is not functioning properly or when the heart has a conductive disorder. It is commonly used: 1) in an emergency; 2) during surgery; or 3) following open-heart surgery until the heart recovers. It is not intended for defibrillation or cardioversion. The leads (not included) are inserted into the heart through a major vein (e.g., subclavian) or attached directly to the heart wall.
GUDID devices
42
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00613994361059STREAMLINE™MEDTRONIC, INC.6492F2015-06-19
00613994361066STREAMLINE™MEDTRONIC, INC.6500F2015-06-19
00613994365415STREAMLINE™MEDTRONIC, INC.6491F2015-06-19
00613994365422STREAMLINE™MEDTRONIC, INC.6494F2015-06-19
00613994365439STREAMLINE™MEDTRONIC, INC.6495F2015-06-19
00613994755629DETECT®MEDTRONIC, INC.106502015-06-23
00850056280006SoloPace Fusion Ground PadSOLO PACE INC.7050910012026-02-05
00850056280044SoloPace Fusion Sterile PackSOLO PACE INC.K12-126212026-02-05
00850056280051SoloPace Fusion KitSOLO PACE INC.SOLOFUSE12026-02-05
20850056280055SoloPace Fusion Kit Shipping CaseSOLO PACE INC.SOLOFUSE12026-02-05
00850056280020SoloPace EPGSOLO PACE INC.SOLOEPG12026-02-02
00850056280013Solo Pace Control SystemSOLO PACE INC.SOLORCM2025-01-23
00850056280037Solo Pace Control SystemSOLO PACE INC.SOLOEPG1L2025-01-23
04260451441050CARDIOTRONIC Osypka Medical GmbHPACE 1012021-04-30
04260451441067CARDIOTRONIC Osypka Medical GmbHPACE 2032021-04-30
04260451441173Osypka MedicalOsypka Medical GmbHPSA 2002021-04-30
00836559008859PACE 101HOscor Inc.PACE 101H2016-09-09
00836559008866PACE 203HOscor Inc.PACE 203H2016-09-09
04260451441012CARDIOTRONIC Osypka Medical GmbHPACE 1012016-09-13
04260451441029CARDIOTRONIC Osypka Medical GmbHPACE 2032016-09-13
00863019000306BloomFischer Medical206276G2016-09-12
00863019000313BloomFischer Medical106459G2016-09-12
00863019000320BloomFischer Medical108419G-22016-09-12
00885672005467PACE 203HOscor Inc.PACE 203H LOANER2016-09-17
00763000162443NAMEDTRONIC, INC.53922018-11-11
00643169230859NAMEDTRONIC, INC.53922014-09-23
20643169310074STREAMLINE™MEDTRONIC, INC.6491F2016-02-17
20643169310081STREAMLINE™MEDTRONIC, INC.6492F2016-02-17
20643169310098STREAMLINE™MEDTRONIC, INC.6494F2016-02-17
20643169310104STREAMLINE™MEDTRONIC, INC.6495F2016-02-17
20643169310111STREAMLINE™MEDTRONIC, INC.6500F2016-02-17
006431693829785391Oscor Inc.53912016-09-09
00643169508767NAMEDTRONIC, INC.53922014-11-13
00643169723160NAMEDTRONIC, INC.534012017-03-12
00643169725126NAMEDTRONIC, INC.53922017-01-29
20613994361053STREAMLINE™MEDTRONIC, INC.6492F2015-06-19
20613994361060STREAMLINE™MEDTRONIC, INC.6500F2015-06-19
20613994365419STREAMLINE™MEDTRONIC, INC.6491F2015-06-19
20613994365426STREAMLINE™MEDTRONIC, INC.6494F2015-06-19
20613994365433STREAMLINE™MEDTRONIC, INC.6495F2015-06-19
00613994377890DETECT®MEDTRONIC, INC.106502015-09-21
20613994755623DETECT®MEDTRONIC, INC.106502015-06-23