Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | OMNICARBON CARDIAC VALVE PROSTHESIS |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDICALCV, INC. 9725 SOUTH ROBERT TRAIL INVER GROVE HEIGHTS, MN 55077 |
PMA Number | P830039 |
Supplement Number | S007 |
Date Received | 10/24/1996 |
Decision Date | 07/26/2001 |
Withdrawal Date
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09/17/2007 |
Product Code |
LWQ |
Docket Number | 01M-0380 |
Notice Date | 09/05/2001 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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