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 Oracel 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 | S008 |
Date Received | 07/24/2019 |
Decision Date | 09/12/2019 |
Product Code |
MVC |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Adding a second supplier for a reagent. |
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