Product code OJX
- Device name
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P080006S192 | Attain Ability Lead, Attain Performa Lead (4398,4598), Attain Performa Lead (4298), Attain Stability Quad MRI Lead | Medtronic, Inc. | 2026-04-15 |
| P060039S119 | Attain StarFix Lead | Medtronic, Inc. | 2026-02-10 |
| P080006S191 | MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD | Medtronic, Inc. | 2025-05-14 |
| P080006S190 | Medtronic Attain Ability Model 4196 Lead | Medtronic, Inc. | 2025-03-20 |
| P060039S118 | Attain Starfix Model 4195 Lead | Medtronic, Inc. | 2025-03-20 |
| P080006S189 | Attain Ability Lead | Medtronic, Inc. | 2025-02-26 |
| P080006S188 | Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2025-01-22 |
| P080006S187 | Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2024-11-13 |
| P060039S117 | Attain StarFix Lead | Medtronic, Inc. | 2024-11-13 |
| P080006S186 | Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2024-10-17 |
| P060039S116 | Attain StarFix Lead | Medtronic, Inc. | 2024-10-17 |
| P080006S185 | Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2024-08-01 |
| P080006S184 | Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2024-06-27 |
| P080006S183 | Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2024-04-16 |
| P080006S182 | Attain Ability Lead | Medtronic, Inc. | 2023-12-13 |
| P080006S180 | Attain Performa Lead | Medtronic, Inc. | 2023-11-17 |
| P080006S181 | Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2023-11-08 |
| P080006S179 | Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2023-11-03 |
| P060039S115 | Attain StarFix Lead | Medtronic, Inc. | 2023-11-03 |
| P080006S178 | Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2023-08-01 |
| P060039S114 | ATTAIN STARFIX MODEL 4195 LEAD | Medtronic, Inc. | 2023-08-01 |
| P080006S177 | Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead, | Medtronic, Inc. | 2023-07-11 |
| P080006S175 | Attain Stability Quad MRI Surescan | Medtronic, Inc. | 2023-03-17 |
| P080006S174 | Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2023-02-06 |
| P060039S113 | Attain StarFix Lead | Medtronic, Inc. | 2023-02-06 |
| P080006S173 | Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead | Medtronic, Inc. | 2022-11-22 |
| P060039S112 | Attain StarFix Lead | Medtronic, Inc. | 2022-11-22 |
| P080006S172 | Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2022-06-01 |
| P060039S111 | Attain StarFix Lead | Medtronic, Inc. | 2022-06-01 |
| P080006S171 | Attain Performa Lead, Attain Stability Quad MRI Lead | Medtronic, Inc. | 2022-05-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05414734510196 | Quartet™ | ST. JUDE MEDICAL, INC. | 2025-10-02 |
| 00643169860230 | Attain Ability™ Straight MRI SureScan™ | MEDTRONIC, INC. | 2017-03-26 |
| 00643169860223 | Attain Ability™ Straight MRI SureScan™ | MEDTRONIC, INC. | 2017-03-26 |
| 00643169860032 | Attain Ability™ MRI SureScan™ | MEDTRONIC, INC. | 2017-03-24 |
| 00643169601772 | Attain Ability™ MRI SureScan™ | MEDTRONIC, INC. | 2016-02-26 |
| 00643169601871 | Attain Performa™ S MRI SureScan™ | MEDTRONIC, INC. | 2016-02-26 |
| 00643169601840 | Attain Performa™ Straight MRI SureScan™ | MEDTRONIC, INC. | 2016-02-26 |
| 00643169601833 | Attain Performa™ MRI SureScan™ | MEDTRONIC, INC. | 2016-02-26 |
| 00643169601826 | Attain Performa™ MRI SureScan™ | MEDTRONIC, INC. | 2016-02-26 |
| 00643169601819 | Attain Ability™ Straight MRI SureScan™ | MEDTRONIC, INC. | 2016-02-26 |
| 00643169601802 | Attain Ability™ Straight MRI SureScan™ | MEDTRONIC, INC. | 2016-02-26 |
| 00643169601796 | Attain Ability™ Plus MRI SureScan™ | MEDTRONIC, INC. | 2016-02-26 |
| 00643169601765 | Attain Ability™ MRI SureScan™ | MEDTRONIC, INC. | 2016-02-26 |
| 00643169590595 | ATTAIN® BIPOLAR OTW | MEDTRONIC, INC. | 2016-01-14 |
| 00643169590571 | ATTAIN® BIPOLAR OTW | MEDTRONIC, INC. | 2016-01-14 |
| 00643169169081 | ATTAIN® PERFORMA™ S | MEDTRONIC, INC. | 2014-12-16 |
| 00643169169036 | ATTAIN® PERFORMA™ S | MEDTRONIC, INC. | 2014-12-16 |
| 00643169002517 | ATTAIN® PERFORMA™ STRAIGHT | MEDTRONIC, INC. | 2014-12-16 |
| 00613994719058 | Attain Ability® Straight | MEDTRONIC, INC. | 2014-09-23 |
| 00885074511986 | ATTAIN STARFIX® | MEDTRONIC, INC. | 2014-09-23 |
| 00885074200729 | ATTAIN® OTW | MEDTRONIC, INC. | 2014-09-23 |
| 00885074200743 | ATTAIN® OTW | MEDTRONIC, INC. | 2014-09-23 |
| 00643169002715 | Attain® Performa™ | MEDTRONIC, INC. | 2014-09-23 |
| 00643169002685 | Attain® Performa™ | MEDTRONIC, INC. | 2014-09-23 |
| 00613994719171 | Attain Ability® Plus | MEDTRONIC, INC. | 2014-09-23 |
| 00613994469731 | Attain Ability® | MEDTRONIC, INC. | 2014-09-23 |
| 04035479093532 | Corox | BIOTRONIK SE & Co. KG | 2014-08-06 |
| 04035479093549 | Corox | BIOTRONIK SE & Co. KG | 2014-08-06 |
| 04035479094157 | Corox | BIOTRONIK SE & Co. KG | 2014-08-06 |
| 04035479094164 | Corox | BIOTRONIK SE & Co. KG | 2014-08-06 |