Product code DYE
- Device name
- Replacement Heart-Valve
- Medical specialty
- Cardiovascular
- Device class
- 3
- Regulation number
- 870.3925
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P860057S226 | Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis | Edwards Lifesciences, LLC | 2026-06-03 |
| P860057S225 | Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve, Carpentier-Edwards PERIMOUNT Magna Mitral Ease Bioprosthesis | Edwards Lifesciences, LLC | 2026-04-16 |
| P860057S224 | Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process; Carpentier-Edwar | Edwards Lifesciences, LLC | 2026-03-11 |
| P990064S094 | Mosaic Neo Mitral Bioprosthesis | Medtronic, Inc. | 2026-03-03 |
| P990064S096 | Mosaic Bioprosthesis | Medtronic, Inc. | 2026-02-12 |
| P980043S086 | Hancock II Bioprosthesis | Medtronic, Inc. | 2026-02-12 |
| P990064S093 | Mosaic Bioprosthesis | Medtronic, Inc. | 2025-11-10 |
| P980043S084 | Hancock II Bioprosthesis | Medtronic, Inc. | 2025-11-10 |
| P990064S095 | Mosaic Bioprosthesis, Models 305, 310 | Medtronic, Inc. | 2025-10-23 |
| P980043S085 | Hancock II Bioprosthesis, Models T505, T510 | Medtronic, Inc. | 2025-10-23 |
| P860057S223 | Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi | Edwards Lifesciences, LLC | 2025-10-16 |
| P990064S092 | Mosaic Bioprosthesis, Models 305, 310 | Medtronic, Inc. | 2025-06-26 |
| P980043S083 | Hancock II Bioprosthesis, Models T505, T510 | Medtronic, Inc. | 2025-06-26 |
| P990064S091 | Mosaic Bioprosthesis | Medtronic, Inc. | 2025-04-16 |
| P980043S082 | Hancock II Bioprosthesis | Medtronic, Inc. | 2025-04-16 |
| P860057S220 | PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis | Edwards Lifesciences, LLC | 2025-04-10 |
| P860057S221 | Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses | Edwards Lifesciences, LLC | 2025-02-20 |
| P990064S089 | Mosaic™ Bioprosthesis | Medtronic, Inc. | 2025-01-22 |
| P980043S080 | Hancock II™ Bioprosthesis | Medtronic, Inc. | 2025-01-22 |
| P860057S219 | Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN | Edwards Lifesciences, LLC | 2024-09-12 |
| P860057S218 | Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN | Edwards Lifesciences, LLC | 2024-05-23 |
| P990064S088 | Mosaic Bioprosthesis | Medtronic, Inc. | 2024-04-22 |
| P980043S079 | Hancock II Bioprosthesis | Medtronic, Inc. | 2024-04-22 |
| P870078S051 | Hancock Valved Conduit | Medtronic, Inc. | 2024-04-22 |
| P860057S217 | Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses | Edwards Lifesciences, LLC | 2024-03-25 |
| P860057S216 | Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses | Edwards Lifesciences, LLC | 2024-02-13 |
| P860057S214 | Carpentier-Edwards PERIMOUNT Aortic and Mitral Surgical Heart Valves | Edwards Lifesciences, LLC | 2023-12-11 |
| P860057S215 | Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr | Edwards Lifesciences, LLC | 2023-12-06 |
| P990064S087 | Mosaic Bioprosthesis | Medtronic, Inc. | 2023-11-28 |
| P980043S078 | Hancock II Bioprosthesis | Medtronic, Inc. | 2023-11-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000990558 | Mosaic Neo™ 310 | MEDTRONIC, INC. | 2026-04-13 |
| 00763000990565 | Mosaic Neo™ 310 | MEDTRONIC, INC. | 2026-04-13 |
| 00763000990572 | Mosaic Neo™ 310 | MEDTRONIC, INC. | 2026-04-13 |
| 00763000990589 | Mosaic Neo™ 310 | MEDTRONIC, INC. | 2026-04-13 |
| 00763000990596 | Mosaic Neo™ 310 | MEDTRONIC, INC. | 2026-04-13 |
| 00763000926472 | Hancock™ 150 | MEDTRONIC, INC. | 2024-07-22 |
| 00763000926465 | Hancock™ 150 | MEDTRONIC, INC. | 2024-07-22 |
| 00643169983229 | Avalus™ | MEDTRONIC, INC. | 2024-03-09 |
| 00690103194104 | CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS | Edwards Lifesciences LLC | 2019-11-27 |
| 00690103194098 | CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS | Edwards Lifesciences LLC | 2019-11-27 |
| 00690103194081 | CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTIC | Edwards Lifesciences LLC | 2019-11-27 |
| 00690103194074 | CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTIC | Edwards Lifesciences LLC | 2019-11-27 |
| 00690103194128 | CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS | Edwards Lifesciences LLC | 2019-08-09 |
| 00690103194029 | CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis | Edwards Lifesciences LLC | 2019-02-21 |
| 00690103194050 | CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis | Edwards Lifesciences LLC | 2019-02-21 |
| 00690103194036 | CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis | Edwards Lifesciences LLC | 2019-02-21 |
| 00690103194043 | CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis | Edwards Lifesciences LLC | 2019-02-21 |
| 00690103194012 | CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis | Edwards Lifesciences LLC | 2019-02-21 |
| 00690103194067 | CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis | Edwards Lifesciences LLC | 2019-02-21 |
| 00681490908474 | HANCOCK® | MEDTRONIC, INC. | 2014-09-23 |
| 00613994686824 | HANCOCK® II | MEDTRONIC, INC. | 2014-09-23 |
| 00681490908504 | HANCOCK® | MEDTRONIC, INC. | 2014-09-23 |
| 00613994772732 | HANCOCK II ULTRA® | MEDTRONIC, INC. | 2014-09-23 |
| 00613994772725 | HANCOCK II ULTRA® | MEDTRONIC, INC. | 2014-09-23 |
| 00613994772718 | HANCOCK II ULTRA® | MEDTRONIC, INC. | 2014-09-23 |
| 00613994760579 | HANCOCK® II | MEDTRONIC, INC. | 2014-09-23 |
| 00613994760562 | HANCOCK® II | MEDTRONIC, INC. | 2014-09-23 |
| 00613994760555 | HANCOCK® II | MEDTRONIC, INC. | 2014-09-23 |
| 00613994760548 | HANCOCK® II | MEDTRONIC, INC. | 2014-09-23 |
| 00613994686961 | HANCOCK® II | MEDTRONIC, INC. | 2014-09-23 |