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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.
 
DeviceEMDOGAIN GEL
Generic NameBiologic material, dental
Regulation Number872.3930
ApplicantTHE STRAUMANN COMPANY
60 Minuteman Road
Andover, MA 01810
PMA NumberP930021
Supplement NumberS005
Date Received07/26/2000
Decision Date06/04/2002
Product Code NQA 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE REVISIONS TO THE PACKAGE INSERT AS LISTED BELOW BASED ON NEW DATA THAT HAS BEEN PRESENTED IN THIS PMA SUPPLEMENT. 1) INCLUSION OF THE FOLLOWING STATEMENT IN THE CLINICAL CONSIDERATIONS SECTION: "HISTOLOGICAL STUDIES HAVE DEMONSTRATED RESULTS RANGING FROM COMPLETE PERIODONTAL REGENERATION (NEWLY FORMED CEMENTUM, PERIODONTAL LIGAMENT, AND ALVEOLAR BONE) TO REPAIR INCLUDING NEW CONNECTIVE TISSUE ATTACHMENT (CONNECTIVE TISSUE ADAPTATION VIA NEW CEMENTUM) AND A NEW ATTACHMENT MEDIATED BY AN EPITHELIAL ATTACHMENT (LONG JUNCTIONAL EPITHELIUM). THE LONG-TERM STABILITY OF THE REGENERATED TISSUE HAS NOT BEEN ESTABLISHED. AS IN ANY PERIODONTAL SURGICAL THERAPY, DEFECT MORPHOLOGY, SURGICAL TECHNIQUE AND HOST RESPONSE ARE IMPORTANT PARAMETERS FOR SUCCESSFUL OUTCOMES." 2) INCLUSION OF THE FOLLOWING STATEMENTS IN THE CLINICAL CONSIDERATIONS SECTION: A) PATIENTS TEND TO REPORT LESS POST-SURGICAL DISCOMFORT; B) CLINICIANS HAVE REPORTED ON ENHANCED WOUND HEALING.
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