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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS007
Date Received08/17/1998
Decision Date09/02/1999
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modified stability testing specifications, and a modified quality control procedure for monitoring acceptability of specimen processing reagents. The supplement included a protocol for assessing effectiveness of user controls with rrna controls and a stability testing protocol using the 15 minute selection time that were specific conditions for postapproval requirements described in the approval order for p940034/s004.