PMA P930021S011

Device: EMDOGAIN
Applicant: The Straumann Company
PMA number: P930021
Supplement: S011
Product code: NQA
Decision date: 2009-06-19
Classification: Biologic Material, Dental
Generic name: Biologic material, dental
Approval order statement: APPROVAL FOR THE FOLLOWING: 1) THE USE OF STRAUMANN EMDOGAIN WITH BONE SUBSTITUTE MATERIAL, SUCH AS STRAUMANN BONE CERAMIC; 2) LABELING CHANGES TO MODIFY A STATEMENT REGARDING THE LONG TERM STABILITY OF REGENERATED TISSUE; 3) LABELING CHANGE TO ADD ADDITIONAL SURGICAL TECHNIQUES FOR THE TREATMENT OF GINGIVAL RECESSION DEFECTS; 4) LABELING CHANGE TO INCLUDE INSTRUCTIONS IN THE ¿STORAGE¿ SECTION IN INSTRUCTIONS FOR USE FOR HOMOGENIZATION IF THE MATERIAL IS SEPARATED IN THE SYRINGE; AND 5) CLARIFY THE INSTRUCTIONS UNDER EACH OF THE THREE CLINICAL PROCEDURES IN THE INSTRUCTIONS FOR USE TO BETTER ALIGN THEM WITH ONE ANOTHER.

Current openFDA PMA Record#

Device: EMDOGAIN
Applicant: The Straumann Company
PMA number: P930021
Supplement: S011
Product code: NQA
Generic name: Biologic material, dental
Decision date: 2009-06-19
Decision code: APPR
Date received: 2008-03-27
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE FOLLOWING: 1) THE USE OF STRAUMANN EMDOGAIN WITH BONE SUBSTITUTE MATERIAL, SUCH AS STRAUMANN BONE CERAMIC; 2) LABELING CHANGES TO MODIFY A STATEMENT REGARDING THE LONG TERM STABILITY OF REGENERATED TISSUE; 3) LABELING CHANGE TO ADD ADDITIONAL SURGICAL TECHNIQUES FOR THE TREATMENT OF GINGIVAL RECESSION DEFECTS; 4) LABELING CHANGE TO INCLUDE INSTRUCTIONS IN THE ¿STORAGE¿ SECTION IN INSTRUCTIONS FOR USE FOR HOMOGENIZATION IF THE MATERIAL IS SEPARATED IN THE SYRINGE; AND 5) CLARIFY THE INSTRUCTIONS UNDER EACH OF THE THREE CLINICAL PROCEDURES IN THE INSTRUCTIONS FOR USE TO BETTER ALIGN THEM WITH ONE ANOTHER.