SULZER CARBOMEDICS ORBIS PROSTHETIC HEART VALVE
FDA premarket approval P900060/S018 · decided 1999-03-17
Approval details
- PMA number
- P900060
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SULZER CARBOMEDICS ORBIS PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 1998-09-18
- Decision date
- 1999-03-17
- Days to decision
- 180 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 Sulzer Carbomedics Orbis(TM) Prosthetic Heart Valve and will be available in the following model numbers and sizes: Model 100 (aortic sizes 19, 21, 23, 25, 27, 29, and 31mm), and Model 200 (mitral sizes 21, 23, 25, 27, 29, 31, and 33mm).
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