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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSALEST SYSTEM
ApplicantHologic, Inc.
1240 Elko Dr.
Sunnyvale, CA 94089
PMA NumberP970032
Supplement NumberS001
Date Received07/09/1999
Decision Date08/26/1999
Withdrawal Date06/15/2016
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a contract packaging site located at Biotecnica Continental SA DE CV, Libramiento Oriente 124-C, Tijuana, BC 22490, Mexico.
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