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 | Vysis ALK Break Apart FISH Probe Kit |
Generic Name | Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement |
Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P110012 |
Supplement Number | S011 |
Date Received | 09/02/2016 |
Decision Date | 09/29/2016 |
Product Code |
OWE |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Location change for a component supplier. |
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