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 LOW POROSITY CONDUIT MODEL 105 |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | Medtronic, Inc. 1851 E. Deere Avenue Santa Ana, CA 92705 |
PMA Number | P870078 |
Supplement Number | S015 |
Date Received | 03/23/2012 |
Decision Date | 01/10/2013 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE GLUTARALDEHYDE STOCK SOLUTION THAT IS OBTAINED FROM DOWCHEMICAL FOR THE FIXATIVE, STORAGE, AND STERILIZATION SOLUTIONS TO BE CHANGED FROM A 25% STOCK SOLUTION TO A 50% STOCK SOLUTION. |
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