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 | PATHVYSION HER-2 DNA PROBE KIT |
Generic Name | SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM |
Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P980024 |
Supplement Number | S005 |
Date Received | 02/22/2011 |
Decision Date | 04/18/2011 |
Product Code |
MVD |
Advisory Committee |
Pathology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE IMPLEMENTATION OF PROCESS CHANGES TO THE MANUFACTURE OF THE PATHVYSION HER-2 DNA PROBE KIT ASSAY, INCLUDING A NEW FISH DNA EXTRACTION PROCESS, AND RNA REDUCTION STEP, NEW SONICATION EQUIPMENT, AND A NEW AMINATION/LABELING PROCEDURE. |
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