CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V
FDA premarket approval P900060/S068 · decided 2025-05-15
Approval details
- PMA number
- P900060
- Supplement
- S068
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2025-02-14
- Decision date
- 2025-05-15
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- approval for the introduction of a new supplier of PET fabric, sewing changes impacting the cuff component of CPHV devices, and the removal of the Carbofilm coating from PET fabric
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MEMO 4D Curve™ Semirigid mitral annuloplasty ring (K261707) | Corcym S.r.l. | 2026-06-18 |
| TriMemo™ SEMIRIGID ANNULOPLASTY RING (K260498) | Corcym S.r.l. | 2026-04-14 |
| Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring (K230318) | Corcym S.r.l. | 2023-04-07 |