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 | ELECSYS FREE PSA IMMUNOASSAY |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P000027 |
Supplement Number | S009 |
Date Received | 04/11/2011 |
Decision Date | 06/20/2011 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE MANUFACTURING SITE FROM BUILDINGS 341, 345 AND 651 TO BUILDING 761, ALL WITHIN THE ROCHE PENZBERG, GERMANY FACILITY. |
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