PMA P830039S007
- Device
- OMNICARBON CARDIAC VALVE PROSTHESIS
- Applicant
- Medical Cv, Inc.
- PMA number
- P830039
- Supplement
- S007
- Product code
- LWQ
- Decision date
- 2001-07-26
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P830039S007B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- OMNICARBON CARDIAC VALVE PROSTHESIS
- Applicant
- Medical Cv, Inc.
- PMA number
- P830039
- Supplement
- S007
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2001-07-26
- Decision code
- APPR
- Date received
- 1996-10-24
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.