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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePERIOGARD PERIODONTAL TISSUE MONITOR
ApplicantXytronyx, Inc.
6730 Mesa Ridge Rd., Suite A
San Diego, CA 92121
PMA NumberP960031
Date Received09/19/1996
Decision Date06/23/1997
Withdrawal Date02/11/2011
Docket Number 98M-0036
Notice Date 01/27/1998
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 
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