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 | S010 |
Date Received | 06/01/2016 |
Decision Date | 07/13/2016 |
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 | Yes |
Approval Order Statement Removal of testing at the cell pellet stage for 2 components of the PathVysion HER-2 DNA Probe Kit: (1) ProbeChek HER-2/neu Cut-Off Control Slides (List No. 02J04-030), (2) ProbeChek HER-2/neu Normal Control Slides (List No. 02J05-030). The second change involves adding the RM2255 Rotary Microtome to the manufacturing procedures of the ProbeChek HER-2/neu Cut-Off Control Slides, the ProbeChek Her-2/neu Normal Control Slides, and 2 components of the Vysis ALK Break Apart FISH Probe Kit: (1) ProbeChek ALK Negative Control Slides (06N38-005), (2) ProbeChek ALK Postitive Control Slides (06N38-010). |
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