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 | APTIMA HPV ASSAY |
Generic Name | Kit, rna detection, human papillomavirus |
Applicant | GEN-PROBE INCORPORATED 10210 Genetic Center Drive San Diego, CA 92121 |
PMA Number | P100042 |
Supplement Number | S009 |
Date Received | 10/16/2015 |
Decision Date | 11/09/2015 |
Product Code |
OYB |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A VIAL FILLER FOR USE IN MANUFACTURING AND EXPANSION OF FILL VOLUME SPECIFICATIONS. |
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