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 | SALEST SYSTEM |
Applicant | HOLOGIC, INC. 1240 Elko Drive Sunnyvale, CA 94089 |
PMA Number | P970032 |
Supplement Number | S001 |
Date Received | 07/09/1999 |
Decision Date | 08/26/1999 |
Withdrawal Date
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06/15/2016 |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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