OMNICARBON CARDIAC VALVE PROSTHESIS
FDA premarket approval P830039/S011 · decided 2002-10-29
Approval details
- PMA number
- P830039
- Supplement
- S011
- Supplement type
- Normal 180 Day 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
- 2002-05-07
- Decision date
- 2002-10-29
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Inver Grove Heights, MN
- Statement
- APPROVAL FOR THE OMNICARBON CARDIAC VALVE PROSTHESIS IN THE ADDITIONAL SIZE OF 21 MM OF THE MODEL 3313 (AORTIC) AND SIZE 25 MM OF THE MODEL 3523 (MITRAL). THE SUPPLEMENT REQUESTED APPROVAL OF THESE SIZES AS AN ADDITION TO THE EXISTING, APPROVED (JULY 26, 2001; P830039/S007) PRODUCT LINE OF AORTIC SIZES 23, 25, 27 AND 29 MM, AND MITRAL SIZES 27, 29, 31, AND 33 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC AND MITRAL VALVES.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |