Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3610](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3610) → DXY — Implantable Pacemaker Pulse-Generator # DXY · Implantable Pacemaker Pulse-Generator _Cardiovascular · 21 CFR 870.3610 · Class 3_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY ## Overview - **Product Code:** DXY - **Device Name:** Implantable Pacemaker Pulse-Generator - **Regulation:** [21 CFR 870.3610](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3610) - **Device Class:** 3 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Implant:** yes ## Identification An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body. ## Classification Rationale Class III (premarket approval). ## Recent Cleared Devices (20 of 471) Showing 20 most recent of 471 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K993434](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K993434.md) | PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A | Biotronik, Inc. | Nov 10, 1999 | SESE | | [K970072](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K970072.md) | OPUS S MODEL 4121 AND 4124 PACEMAKERS | Ela Medical, Inc. | Aug 29, 1997 | ST | | [P950029](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/P950029.md) | CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER | MicroPort CRM USA, Inc. | Mar 10, 1997 | APPR | | [P950037](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/P950037.md) | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS | Biotronik, Inc. | Oct 11, 1996 | APPR | | [K945627](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K945627.md) | PIKOS LP 01, PIKOS LP E01 | Biotronik, Inc. | Mar 4, 1996 | SESP | | [K954092](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K954092.md) | ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) | Medtronic Vascular | Dec 15, 1995 | ST | | [K953866](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K953866.md) | MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) | Medtronic Vascular | Dec 15, 1995 | ST | | [K953417](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K953417.md) | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | Cook Pacemaker Corp. | Sep 29, 1995 | ST | | [K952328](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K952328.md) | NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 | Biotronik, Inc. | Sep 29, 1995 | ST | | [K952364](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K952364.md) | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) | Ela Medical, Inc. | Sep 1, 1995 | ST | | [K940039](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K940039.md) | PELLETHANE 75D | Medtronic Vascular | Jul 12, 1995 | ST | | [P940031](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/P940031.md) | VIGOR(TM) DR PACEMAKER SYSTEM | Boston Scientific | Jun 21, 1995 | APPR | | [K950751](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K950751.md) | TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES | Medtronic Vascular | May 15, 1995 | ST | | [K946188](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K946188.md) | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | Cardiac Control Systems, Inc. | May 15, 1995 | ST | | [K950210](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K950210.md) | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER | Cardiac Control Systems, Inc. | May 3, 1995 | ST | | [K941937](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K941937.md) | PIKOS E 01-B | Biotronik, Inc. | Aug 30, 1994 | SESP | | [K932884](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K932884.md) | MINIX/MINIX ST PULSE GENERATORS | Medtronic Vascular | May 2, 1994 | SESP | | [K923026](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K923026.md) | PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER | Biotronik, GmbH & Co. | Aug 19, 1993 | SESE | | [K930770](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K930770.md) | MEDTRONIC MINIX & MINIX ST PULSE GENERATORS | Medtronic Vascular | May 14, 1993 | SESE | | [K923868](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K923868.md) | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | Cardiac Control Systems, Inc. | May 14, 1993 | SESE | ## Top Applicants - Medtronic Vascular — 59 clearances - Intermedics, Inc. — 52 clearances - Telectronics, Inc. — 47 clearances - Cardiac Pacemakers, Inc. — 37 clearances - Pacesetter Systems — 28 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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