CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
FDA premarket approval P860057/S056 · decided 2009-07-09
Approval details
- PMA number
- P860057
- Supplement
- S056
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2009-05-01
- Decision date
- 2009-07-09
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A NEW DEVICE TRADE NAME AND MODEL NUMBER TO ADD TO THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS FAMILY. MODEL 7200TFX IS IDENTICAL TO THE PREVIOUSLY APPROVED MODEL 7000TFX WITH THE EXCEPTION OF A DIFFERENT SIZING CONVENTION. THERE ARE NO CHANGES TO THE DIMENSIONS OF THE DEVICE OR THE INDICATIONS FOR USE. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESISMODEL 7200TFX AND IS INDICATED FO
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
| HemoSphere Nano Monitor (HSNANO1) (K253186) | Edwards Lifesciences, LLC | 2026-02-24 |
| Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982) | Edwards Lifesciences, LLC | 2025-09-23 |
| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
| Hypertension Prediction Index (HePI) Algorithm (K242518) | Edwards Lifesciences, LLC | 2025-05-15 |
| FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909) | Edwards Lifesciences, LLC | 2025-03-21 |
| Fogarty Thru-Lumen Embolectomy Catheter (K240078) | Edwards Lifesciences, LLC | 2024-08-28 |
| Acumen Assisted Fluid Management (AFM) Software Feature (K233984) | Edwards Lifesciences, LLC | 2024-08-02 |