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 | COLOGUARD |
Generic Name | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
Applicant | Exact Sciences Corporation 441 Charmany Drive Madison, WI 53719 |
PMA Number | P130017 |
Supplement Number | S007 |
Date Received | 03/22/2016 |
Decision Date | 04/20/2016 |
Product Code |
PHP |
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 Relocation within current facility of manual dispensing, label printing, and kitting activities. |
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