Premarket Approval (PMA)

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.

• Device: PERIOGARD PERIODONTAL TISSUE MONITOR
• Applicant: Xytronyx, Inc.; 6730 Mesa Ridge Rd., Suite A; San Diego, CA 92121
• PMA Number: P960031
• Supplement Number: S001
• Date Received: 08/26/1997
• Decision Date: 09/30/1997
• Withdrawal Date: 02/11/2011
• Advisory Committee: Clinical Chemistry
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No