Product code LWO
- Device name
- Pulse-Generator, Single Chamber, Sensor Driven, Implantable
- Medical specialty
- Unknown
- Device class
- 3
- 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 |
|---|---|---|---|
| P970013S097 | Microny family of Pacemakers | ABBOTT MEDICAL | 2025-06-17 |
| P970013S098 | Microny II SR+ | ABBOTT MEDICAL | 2025-05-22 |
| P970013S094 | Microny family of Pacemakers | ABBOTT MEDICAL | 2025-04-01 |
| P850051S085 | Activitrax Models 8400, 8402, 8403 | Medtronic, Inc. | 2025-03-20 |
| P970013S096 | Microny family of Pacemakers | ABBOTT MEDICAL | 2025-02-05 |
| P970013S095 | Microny family of Pacemakers | ABBOTT MEDICAL | 2024-12-18 |
| P970013S093 | Microny | ABBOTT MEDICAL | 2023-12-27 |
| P970013S092 | Microny family of Pacemakers | ABBOTT MEDICAL | 2023-04-14 |
| P970013S091 | Microny family of Pacemakers | ABBOTT MEDICAL | 2022-09-30 |
| P970013S090 | Microny family of Pacemakers | ABBOTT MEDICAL | 2022-05-17 |
| P970013S089 | Microny family of Pacemakers | ABBOTT MEDICAL | 2022-01-07 |
| P970013S085 | Microny family of Pacemakers | ABBOTT MEDICAL | 2021-09-15 |
| P970013S088 | Microny | ABBOTT MEDICAL | 2021-07-07 |
| P970013S087 | Microny family of Pacemakers | ABBOTT MEDICAL | 2021-06-28 |
| P970013S086 | Microny | ABBOTT MEDICAL | 2021-04-09 |
| P970013S084 | Microny | ABBOTT MEDICAL | 2020-10-26 |
| P970013S082 | Microny family of Pacemakers | ABBOTT MEDICAL | 2020-06-30 |
| P970013S083 | Microny | ABBOTT MEDICAL | 2020-02-28 |
| P970013S081 | Microny family of Pacemakers | ABBOTT MEDICAL | 2019-12-23 |
| P970013S080 | Microny Pacemaker | ABBOTT MEDICAL | 2018-12-11 |
| P970013S079 | Microny | ABBOTT MEDICAL | 2018-10-24 |
| P970013S078 | Microny | ABBOTT MEDICAL | 2018-08-14 |
| P970013S076 | Microny family of Pacemakers | ABBOTT MEDICAL | 2018-04-11 |
| P970013S077 | Microny | ABBOTT MEDICAL | 2018-02-22 |
| P970013S075 | Microny family of Pacemakers | ABBOTT MEDICAL | 2017-11-09 |
| P970013S074 | Microny | ABBOTT MEDICAL | 2017-11-08 |
| P970013S070 | Microny SR+ Regency SC+ | ABBOTT MEDICAL | 2017-10-20 |
| P970013S073 | Microny 2525T | ABBOTT MEDICAL | 2017-10-16 |
| P970013S072 | Microny Pacemakers | ABBOTT MEDICAL | 2017-09-11 |
| P970013S071 | Microny family of Pacemakers | ABBOTT MEDICAL | 2017-08-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05415067049575 | Merlin™ | ST. JUDE MEDICAL, INC. | 2025-06-25 |
| 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 |
| 05415067050106 | Entrant™ | ST. JUDE MEDICAL, INC. | 2025-02-11 |
| 05415067050120 | 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 |
| 05415067036384 | Aveir™ | ST. JUDE MEDICAL, INC. | 2023-03-03 |
| 05415067034472 | Aveir™ | ST. JUDE MEDICAL, INC. | 2023-03-03 |
| 05415067031914 | Aveir™ | ST. JUDE MEDICAL, INC. | 2023-03-03 |
| 05415067040404 | NA | ST. JUDE MEDICAL, INC. | 2023-01-09 |
| 05415067031174 | Merlin™ | ST. JUDE MEDICAL, INC. | 2022-08-29 |
| 05415067037121 | Merlin™ | ST. JUDE MEDICAL, INC. | 2022-08-29 |
| 05414734006224 | Microny™ | ST. JUDE MEDICAL, INC. | 2017-02-07 |
| 05414734509732 | Merlin.net | ST. JUDE MEDICAL, INC. | 2016-05-04 |
| 05414734509725 | Merlin™ | ST. JUDE MEDICAL, INC. | 2016-01-27 |
| 05414734504799 | Merlin@home™ | ST. JUDE MEDICAL, INC. | 2015-01-19 |
| 05414734504782 | Merlin@home™ | ST. JUDE MEDICAL, INC. | 2015-01-19 |