SULZER CARBOMEDICS CPHV OPTIFORM VALVE
FDA premarket approval P900060/S019 · decided 1999-06-01
Approval details
- PMA number
- P900060
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SULZER CARBOMEDICS CPHV OPTIFORM VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 1999-05-14
- Decision date
- 1999-06-01
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- Approval for a sewing cuff modification of the CarboMedics(R) Prosthetic Heart Valve. The device, as modified, will be marketed under the trade name CPHV(TM) OptiForm(TM) Valve and will be available in the following model numbers and sizes: Aortic Model F500 (sizes 19, 21, 23, 25, 27, 29, and 31 mm), and Mitral Model F700 (sizes 21, 23, 25, 27, 29, 31, and 33 mm). The device is indicated for the replacement of malfunctioning native or prosthetic aortic or mitral valves.
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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 |