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 | BOND ORACLE HER2 IHC SYSTEM |
Generic Name | SYSTEM, TEST, HER-2/NEU, IHC |
Applicant | Leica Biosystems 36 Cherry Hill Drive Danvers, MA 01923 |
PMA Number | P090015 |
Supplement Number | S001 |
Date Received | 07/26/2013 |
Decision Date | 02/11/2014 |
Product Code |
MVC |
Advisory Committee |
Pathology |
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 MANUFACTURING CHANGES TO THE BOND-MAX SOFTWARE, INSTRUMENT STYLING AND USABILITY, THE REAGENT AND BOND-MAX INSTRUMENT MANUFACTURING PROCESSES, AND ASSOCIATED LABELING CHANGES. |
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