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 | DIMENSION FPSA FLEX REAGENT CARTRIDGE |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE, P O BOX 6101 M/S 514 NEWARK, DE 19714-6101 |
PMA Number | P020027 |
Supplement Number | S018 |
Date Received | 03/08/2012 |
Decision Date | 03/16/2012 |
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 DISCONTINUATION OF AN ABSORBANCE TEST PERFORMED ON NYLON-SURLYN FILM AND SURLYN FILM PRIOR TO RELEASE OF THE FILM FOR SLITTING AND CUVETTE FILM CANISTER ASSEMBLY. |
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