Product code DXY
- Device name
- Implantable Pacemaker Pulse-Generator
- Medical specialty
- Cardiovascular
- Device class
- 3
- Regulation number
- 870.3610
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P950037S292 | Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes | Biotronik, Inc. | 2026-05-15 |
| P950037S290 | Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 SR-T, Evity 8 S | Biotronik, Inc. | 2026-05-07 |
| P950037S285 | Renamic Neo | Biotronik, Inc. | 2026-04-24 |
| P950037S282 | Amvia-Solvia Pulse Generators Scan Duration Extension | Biotronik, Inc. | 2026-03-30 |
| P950037S287 | Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T Enitra 6 DR-T | Biotronik, Inc. | 2026-03-27 |
| P950037S286 | Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En | Biotronik, Inc. | 2026-03-05 |
| P950037S283 | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS | Biotronik, Inc. | 2026-02-11 |
| P950037S284 | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS | Biotronik, Inc. | 2026-02-03 |
| P950037S274 | Solia S 53 377177; Solia S 60 377179 | Biotronik, Inc. | 2025-12-18 |
| P950037S281 | Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53; Siello S 45; Sie | Biotronik, Inc. | 2025-12-10 |
| P950037S272 | Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8 | Biotronik, Inc. | 2025-10-24 |
| P950037S278 | Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- | Biotronik, Inc. | 2025-10-16 |
| P950037S276 | Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En | Biotronik, Inc. | 2025-09-15 |
| P950037S275 | Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En | Biotronik, Inc. | 2025-09-11 |
| P950029S134 | Reply SR; Reply DR; ALIZEA SR 1300; ALIZEA DR 1600; CELEA SR 1100; CELEA DR 1400 | MicroPort CRM USA, Inc. | 2025-07-23 |
| P950037S273 | Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- | Biotronik, Inc. | 2025-06-18 |
| P880086S344 | P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256, | ABBOTT MEDICAL | 2025-06-18 |
| P880086S342 | Assurity, Assurity+, Endurity, Accent family of Pacemakers | ABBOTT MEDICAL | 2025-06-17 |
| P880086S343 | Zephyr XL DR, Zephyr DR, Zephyr SR, Zephyr XL SR, Verity ADX XL VDR | ABBOTT MEDICAL | 2025-05-22 |
| P950037S229 | Home Monitoring System Version 3.52.0 | Biotronik, Inc. | 2025-04-15 |
| P950037S269 | Renamic Neo | Biotronik, Inc. | 2025-04-03 |
| P880086S333 | Assurity, Assurity+, Endurity, Accent family of Pacemakers | ABBOTT MEDICAL | 2025-04-01 |
| P950037S267 | Safio S 53, Setrox S 53, Solia S 45, Solia S 53, Solia S 60, Siello S 45, Siello S 53, Siello S 60 | Biotronik, Inc. | 2025-03-10 |
| P950037S271 | Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 | Biotronik, Inc. | 2025-03-05 |
| P950037S270 | Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 | Biotronik, Inc. | 2025-02-20 |
| P950037S268 | Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 | Biotronik, Inc. | 2025-02-05 |
| P880086S339 | Assurity, Assurity+, Endurity, Accent family of Pacemakers | ABBOTT MEDICAL | 2025-02-05 |
| P880086S341 | Assurity, Assurity +, Endurity, Endurity Core, Endurity, Endurity Core, Zenus, Zenex | ABBOTT MEDICAL | 2024-12-19 |
| P880086S338 | Assurity, Assurity+, Endurity, Accent family of Pacemakers | ABBOTT MEDICAL | 2024-12-18 |
| P950037S266 | Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP | Biotronik, Inc. | 2024-12-06 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993434 | PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A | Biotronik, Inc. | 1999-11-10 |
| K970072 | OPUS S MODEL 4121 AND 4124 PACEMAKERS | Ela Medical, Inc. | 1997-08-29 |
| K945627 | PIKOS LP 01, PIKOS LP E01 | Biotronik, Inc. | 1996-03-04 |
| K954092 | ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) | Medtronic Vascular | 1995-12-15 |
| K953866 | MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) | Medtronic Vascular | 1995-12-15 |
| K953417 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | Cook Pacemaker Corp. | 1995-09-29 |
| K952328 | NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 | Biotronik, Inc. | 1995-09-29 |
| K952364 | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) | Ela Medical, Inc. | 1995-09-01 |
| K940039 | PELLETHANE 75D | Medtronic Vascular | 1995-07-12 |
| K950751 | TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES | Medtronic Vascular | 1995-05-15 |
| K946188 | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | Cardiac Control Systems, Inc. | 1995-05-15 |
| K950210 | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER | Cardiac Control Systems, Inc. | 1995-05-03 |
| K941937 | PIKOS E 01-B | Biotronik, Inc. | 1994-08-30 |
| K932884 | MINIX/MINIX ST PULSE GENERATORS | Medtronic Vascular | 1994-05-02 |
| K923026 | PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER | Biotronik, GmbH & Co. | 1993-08-19 |
| K923868 | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | Cardiac Control Systems, Inc. | 1993-05-14 |
| K930770 | MEDTRONIC MINIX & MINIX ST PULSE GENERATORS | Medtronic Vascular | 1993-05-14 |
| K920601 | ASTRA T2, ASTRA T4, ASTRA T6 | Cardiac Pacemakers, Inc. | 1992-10-28 |
| K920530 | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG | Intermedics, Inc. | 1992-03-17 |
| K920157 | SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER | Schneider Intl., Ltd. | 1992-03-16 |
| K914109 | PIKOS 01 & PIKOS E 01 | Biotronik, GmbH & Co. | 1992-02-26 |
| K905403 | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER | Cook Pacemaker Corp. | 1991-10-16 |
| K913134 | MODEL 4220 | Pace Medical | 1991-08-22 |
| K912545 | MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE | Pace Medical | 1991-07-26 |
| K911122 | 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS | Intermedics, Inc. | 1991-05-16 |
| K905824 | MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE | Cardiac Control Systems, Inc. | 1991-05-16 |
| K905087 | TRIOS 02 | Biotronik, GmbH & Co. | 1991-05-07 |
| K903186 | OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE | Telectronics Pacing Systems, Inc. | 1991-01-18 |
| K904941 | MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE | Cardiac Control Systems, Inc. | 1991-01-03 |
| K904602 | MEDTRONIC MODEL 5301B TEST CABLE | Medtronic Vascular | 1991-01-03 |
Related GUDID Devices#
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|---|---|---|---|
| 05415067049575 | Merlin™ | ST. JUDE MEDICAL, INC. | 2025-06-25 |
| 00763000812058 | NA | MEDTRONIC, INC. | 2025-04-12 |
| 05415067050045 | Neutrino™ | ST. JUDE MEDICAL, INC. | 2025-02-11 |
| 05415067050052 | Gallant™ | ST. JUDE MEDICAL, INC. | 2025-02-11 |
| 05415067050076 | Neutrino™ | ST. JUDE MEDICAL, INC. | 2025-02-11 |
| 05415067050120 | Entrant™ | ST. JUDE MEDICAL, INC. | 2025-02-11 |
| 05415067050106 | Entrant™ | ST. JUDE MEDICAL, INC. | 2025-02-11 |
| 05415067050090 | Gallant™ | ST. JUDE MEDICAL, INC. | 2025-02-11 |
| 05415067034809 | Merlin@home™ | ST. JUDE MEDICAL, INC. | 2024-11-13 |
| 08031527018997 | BlueSky | MICROPORT CRM SRL | 2023-06-23 |
| 05415067040404 | NA | ST. JUDE MEDICAL, INC. | 2023-01-09 |
| 05415067037121 | Merlin™ | ST. JUDE MEDICAL, INC. | 2022-08-29 |
| 00763000181215 | NA | MEDTRONIC, INC. | 2021-05-14 |
| 00763000059477 | NA | MEDTRONIC, INC. | 2018-12-28 |
| 00643169451476 | SPRINT QUATTRO® | MEDTRONIC, INC. | 2016-07-31 |
| 05414734509732 | Merlin.net | ST. JUDE MEDICAL, INC. | 2016-05-04 |
| 05414734509725 | Merlin™ | ST. JUDE MEDICAL, INC. | 2016-01-27 |
| 00643169451452 | SPRINT QUATTRO® | MEDTRONIC, INC. | 2015-02-16 |
| 00643169440852 | SPRINT QUATTRO® | MEDTRONIC, INC. | 2015-02-13 |
| 05414734504799 | Merlin@home™ | ST. JUDE MEDICAL, INC. | 2015-01-19 |
| 05414734504782 | Merlin@home™ | ST. JUDE MEDICAL, INC. | 2015-01-19 |
| 05414734006927 | Identity® | ST. JUDE MEDICAL, INC. | 2014-10-29 |
| 05414734006859 | Integrity® | ST. JUDE MEDICAL, INC. | 2014-10-25 |
| 05414734009546 | Victory® | ST. JUDE MEDICAL, INC. | 2014-10-23 |
| 05414734006897 | Identity® | ST. JUDE MEDICAL, INC. | 2014-10-23 |
| 05414734006873 | Identity® | ST. JUDE MEDICAL, INC. | 2014-10-23 |
| 08031527009629 | Screwdriver | MICROPORT CRM SRL | 2014-09-05 |
| 04035479145286 | TW | BIOTRONIK SE & Co. KG | 2014-08-25 |
| 04035479144784 | BS DF-1 | BIOTRONIK SE & Co. KG | 2014-08-25 |
| 04035479144791 | BS IS-1 | BIOTRONIK SE & Co. KG | 2014-08-04 |