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 | IMAGECHECKER M1000 SYSTEM |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | HOLOGIC, INC. 35 CROSBY DR. BEDFORD, MA 01730 |
PMA Number | P970058 |
Supplement Number | S014 |
Date Received | 07/15/2002 |
Decision Date | 09/13/2002 |
Reclassified Date
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02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A REVISION OF THE LABELING FOR THE DEVICE BASED ON NEW ANALYSIS OF THE ORIGINAL PMA CLINICAL DATA. |
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