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 | S002 |
Date Received | 12/22/2014 |
Decision Date | 01/21/2015 |
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
MANUFACTURING SCALE UP OF THE SELECTION REAGENT USED IN THE PROGENSA PCA3 ASSAY. |
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