Product code LOZ
- Device name
- Artificial Heart
- 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
- Definition
- P030011
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P030011S097 | SynCardia Total Artificial Heart (STAH) System | Syncardia Systems, LLC | 2026-02-20 |
| P030011S096 | SynCardia Total Artificial Heart (STAH) system | Syncardia Systems, LLC | 2025-12-17 |
| P030011S093 | Total Artificial Heart | Syncardia Systems, LLC | 2025-11-19 |
| P030011S081 | Total Artificial Heart | Syncardia Systems, LLC | 2025-06-25 |
| P030011S092 | Total Artificial Heart | Syncardia Systems, LLC | 2024-11-25 |
| P030011S089 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2024-03-04 |
| P030011S088 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2023-11-01 |
| P030011S087 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2023-10-18 |
| P030011S086 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2023-08-09 |
| P030011S085 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2023-08-01 |
| P030011S064 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2023-07-06 |
| P030011S084 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2023-04-12 |
| P030011S080 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2022-11-22 |
| P030011S082 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2022-09-22 |
| P030011S079 | SynCardia temporary Total Artificial Heart System | Syncardia Systems, LLC | 2020-10-28 |
| P030011S077 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2020-05-01 |
| P030011S078 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2020-03-12 |
| P030011S070 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2020-03-05 |
| P030011S076 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2020-01-22 |
| P030011S074 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2019-11-26 |
| P030011S072 | SynCardia temporary Total Artificial Heart (Tah-t) System | Syncardia Systems, LLC | 2019-09-19 |
| P030011S073 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2019-08-15 |
| P030011S071 | SynCardia temporary Total Artificial Heart (TAH-t) System - Companion 2 Driver System | Syncardia Systems, LLC | 2019-07-18 |
| P030011S069 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2019-06-26 |
| P030011S068 | SynCardia temporary Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2019-04-17 |
| P030011S067 | SynCardia temporary Total Artifical Heart (TAH-t) System | Syncardia Systems, LLC | 2019-02-20 |
| P030011S066 | Syncardia Temporary Total Artificial Heart (TAH-T) system | Syncardia Systems, LLC | 2019-01-09 |
| P030011S065 | SynCardia temporaty Total Artificial Heart (TAH-t) System | Syncardia Systems, LLC | 2018-12-17 |
| P030011S062 | SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System | Syncardia Systems, LLC | 2018-07-04 |
| P030011S051 | SynCardia temporary Total Artificial Heart (TAH-t) | Syncardia Systems, LLC | 2018-05-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00858000003152 | SynCardia Companion Drivelines | SYNCARDIA SYSTEMS, LLC | 2025-05-29 |
| 00858000003145 | SynCardia Companion Driver Caddy | SYNCARDIA SYSTEMS, LLC | 2025-05-29 |
| 00858000003244 | SynCardia Freedom® Car Charger | SYNCARDIA SYSTEMS, LLC | 2025-04-24 |
| 00858000003251 | SynCardia Freedom® Battery Charger | SYNCARDIA SYSTEMS, LLC | 2025-04-24 |
| 00858000003268 | SynCardia Freedom® Power Adaptor | SYNCARDIA SYSTEMS, LLC | 2025-04-24 |
| 00858000003275 | SynCardia Freedom® Hospital AC Power Supply | SYNCARDIA SYSTEMS, LLC | 2025-04-24 |
| 00858000003282 | SynCardia Freedom® Home AC Power Supply | SYNCARDIA SYSTEMS, LLC | 2025-04-24 |
| 00858000003299 | SynCardia Freedom® Battery Charger Set Shipping Container | SYNCARDIA SYSTEMS, LLC | 2025-04-24 |
| 00858000003305 | SynCardia Hand Pump Shipping Container | SYNCARDIA SYSTEMS, LLC | 2025-04-24 |
| 00858000003091 | SynCardia 50cc TAH-t Surgical Spares Kit | SYNCARDIA SYSTEMS, LLC | 2025-04-23 |
| 00858000003237 | SynCardia Companion Driver Caddy Shipping Container | SYNCARDIA SYSTEMS, LLC | 2025-04-23 |
| 00858000003220 | SynCardia Companion AC Input Power Cord | SYNCARDIA SYSTEMS, LLC | 2025-04-23 |
| 00858000003213 | SynCardia Companion Hospital Cart Shipping Container | SYNCARDIA SYSTEMS, LLC | 2025-04-23 |
| 00858000003206 | SynCardia Companion Driver Shipping Container | SYNCARDIA SYSTEMS, LLC | 2025-04-23 |
| 00858000003190 | SynCardia Companion Battery Shipping Container | SYNCARDIA SYSTEMS, LLC | 2025-04-23 |
| 00858000003138 | SynCardia Companion Hospital Cart | SYNCARDIA SYSTEMS, LLC | 2025-04-23 |
| 00858000003053 | SynCardia 50cc TAH-t, Clinical | SYNCARDIA SYSTEMS, LLC | 2025-04-23 |
| 00858000003046 | SynCardia 70cc TAH-t Surgical Spares Kit | SYNCARDIA SYSTEMS, LLC | 2025-04-23 |
| 00858000003022 | SynCardia Freedom® Discharge Kit Shipping Container | SYNCARDIA SYSTEMS, LLC | 2025-04-23 |
| 00858000003015 | SynCardia Freedom® Standby Kit Shipping Container | SYNCARDIA SYSTEMS, LLC | 2025-04-23 |
| 00858000003008 | SynCardia temporary Total Artificial Heart System | SYNCARDIA SYSTEMS, LLC | 2015-10-23 |
| 00858000003077 | SynCardia Companion Rechargeable LI-ION Battery | SYNCARDIA SYSTEMS, LLC | 2015-10-23 |
| 00858000003084 | SynCardia Freedom® Onboard Battery | SYNCARDIA SYSTEMS, LLC | 2015-10-23 |
| 00858000003107 | SynCardia Companion 2 Driver | SYNCARDIA SYSTEMS, LLC | 2015-10-23 |
| 00858000003114 | SynCardia Hand Pump | SYNCARDIA SYSTEMS, LLC | 2015-10-23 |
| 00858000003121 | SynCardia Freedom® Driver | SYNCARDIA SYSTEMS, LLC | 2015-10-23 |