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 | MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310 |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P990064 |
Supplement Number | S014 |
Date Received | 02/06/2006 |
Decision Date | 06/05/2006 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO: 1) THE JAR RETAINER USED FOR BOTH THE MITRAL AND AORTIC CONFIGURATIONS OF THE MOSAIC BIOPROSTHESES; 2) THE SERIAL NUMBER TAG FOR MITRAL AND AORTIC CONFIGURATIONS OF THE MOSAIC BIOPROSTHESES; 3) THE VALVE HOLDER FOR THE MOSAIC MITRAL BIOPROSTHESES, AND 4) THE "INSTRUCTIONS FOR USE": TO ACCOMMODATE THE CHANGES IN THE RETAINER, TAG AND MITRAL HOLDER. |
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