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 | HANCOCK II BIOPROSTHESIS |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P980043 |
Supplement Number | S012 |
Date Received | 06/19/2007 |
Decision Date | 08/29/2007 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO REDUCE THE BIOPROSTHESIS RINSING TIME PRIOR TO IMPLANTATION. THE APPROVAL APPLIES TO ALL SIZES OF THE AORTIC AND MITRAL HANCOCK II BIOPROSTHESIS. |
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