Carbomedics Prosthetic Heart Valve; Carbomedics® Supra-annular Prosthetic Heart Valve; Carbo-Seal® Ascending Aortic Pros
FDA premarket approval P900060/S069 · decided 2025-12-17
Approval details
- PMA number
- P900060
- Supplement
- S069
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Carbomedics Prosthetic Heart Valve; Carbomedics® Supra-annular Prosthetic Heart Valve; Carbo-Seal® Ascending Aortic Pros
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2025-11-19
- Decision date
- 2025-12-17
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- removal of an in-process inspection performed on valve sub-assemblies during the manufacturing process
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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 |