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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceAIA-PACK PSA
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantTosoh Bioscience, Inc.
6000 Shoreline Ct., Suite 101
South San Franciso, CA 94080
PMA NumberP910065
Supplement NumberS009
Date Received05/20/2019
Decision Date06/18/2019
Product Code MTF 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling changes to the Tosoh AIA-PACK PSA Test to reflect newly acquired information that enhances the safety of the device as allowed by 21 CFR 814.39(d).
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