OMNICARBON CARDIAC VALVE PROSTHESIS
FDA premarket approval P830039/S007 · decided 2001-07-26
Approval details
- PMA number
- P830039
- Supplement
- S007
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OMNICARBON CARDIAC VALVE PROSTHESIS
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medical Cv, Inc.
- Date received
- 1996-10-24
- Decision date
- 2001-07-26
- Days to decision
- 1736 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Inver Grove Heights, MN
- Statement
- APPROVAL FOR THE OMNICARBON(TM) CARDIAC VALVE PROSTHESIS, AORTIC MODEL 3313 IN SIZES 23, 25, 27, AND 29 MM, AND MITRAL SUPRA-ANNULAR MODEL 3523 IN SIES 27, 29, 31, AND 33 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF DYSFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL HEART VALVES.
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510(k) clearances by this applicant
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|---|---|---|
| ATRILAZE LASER ABLATION SYSTEM (K081457) | Medical Cv, Inc. | 2008-08-08 |
| ATRILAZE MI SURGICAL ABLATION SYSTEM (K061489) | Medical Cv, Inc. | 2007-03-16 |
| ATRILAZE SURGICAL ABLATION SYSTEM (K060680) | Medical Cv, Inc. | 2006-04-11 |
| ATRILAZE MALLEABLE ABLATION PROBE (K052495) | Medical Cv, Inc. | 2005-10-11 |
| ATRILAZE SOFT TISSUE ABLATION SYSTEM (K040744) | Medical Cv, Inc. | 2004-11-30 |
| NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 (K033685) | Medical Cv, Inc. | 2004-08-03 |