PMA P930021S005

Device: EMDOGAIN GEL
Applicant: The Straumann Company
PMA number: P930021
Supplement: S005
Product code: NQA
Decision date: 2002-06-04
Classification: Biologic Material, Dental
Generic name: Biologic material, dental
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.

Current openFDA PMA Record#

Device: EMDOGAIN GEL
Applicant: The Straumann Company
PMA number: P930021
Supplement: S005
Product code: NQA
Generic name: Biologic material, dental
Decision date: 2002-06-04
Decision code: APPR
Date received: 2000-07-26
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.