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 | Progensa PCA3 Assay |
Generic Name | Prostrate cancer genes nucleic acid amplification test system |
Applicant | GEN-PROBE INCORPORATED 10210 Genetic Center Drive San Diego, CA 92121 |
PMA Number | P100033 |
Supplement Number | S010 |
Date Received | 02/21/2019 |
Decision Date | 03/15/2019 |
Withdrawal Date
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04/12/2023 |
Product Code |
OYM |
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 Transfer of quality control (QC) testing from one facility to another. |
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