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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Generic Nameperidontal tissue monitor
PMA NumberP960031
Date Received09/19/1996
Decision Date06/23/1997
Withdrawal Date 02/11/2011
Docket Number 98M-0036
Notice Date 01/27/1998
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the periogard periodontal tissue monitor (ptm). This device is indicated for use as a rapid, chair-side, visual test for the qualitative determination of aspartate aminotransferase (ast) in gingival crevicular fluid. The ptm kit detects elevated levels of ast assocaited with tissue necrosis. It is intended to be used as an objective, biochemical adjunct to traditional methods of monitoring patients to assist in the decision to apply treatment and in the evaluation of treatment effectiveness.
Supplements: S001