|
Device | AIA-PACK PSA |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 |
PMA Number | P910065 |
Supplement Number | S009 |
Date Received | 05/20/2019 |
Decision Date | 06/18/2019 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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). |