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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.
 
DevicePERIOGARD PERIODONTAL TISSUE MONITOR
ApplicantXYTRONYX, INC.
6730 MESA RIDGE RD. SUITE A
SAN DIEGO, CA 92121
PMA NumberP960031
Supplement NumberS001
Date Received08/26/1997
Decision Date09/30/1997
Withdrawal Date 02/11/2011
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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