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 (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES |
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 | S010 |
Date Received | 09/23/2004 |
Decision Date | 11/18/2004 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR ADDITIONAL PRODUCT LINES OF THE MOSAIC PORCINE BIOPROSTHESIS AND THE HANCOCK II BIOPROSTHESIS WHICH WILL USE SMALLER SEWING RING DIAMETERS. |
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