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 | ARCHITECT FREE PSA (LN 6C07) |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2 DEPT 09VB ABBOTT PARK, IL 60064-6070 |
PMA Number | P980007 |
Supplement Number | S039 |
Date Received | 02/24/2015 |
Decision Date | 03/26/2015 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES IN THE PRECURSOR CODE FOR BOVINE SERUM AND HUMAN PROSTATE SPECIFIC ANTIGEN WITH EQUIVALENT MATERIALS FOR THE MANUFACTURE OF THE ARCHITECT FREE PSA AND TOTAL PSA CALIBRATORS, CONTROLS, AND SECONDARY CALIBRATORS. |
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