PMA P930021S008

Device: EMDOGAIN GEL
Applicant: The Straumann Company
PMA number: P930021
Supplement: S008
Product code: NQA
Decision date: 2003-12-02
Classification: Biologic Material, Dental
Generic name: Biologic material, dental
Approval order statement: APPROVAL FOR THE ADDITION OF THE FOLLOWING INDICATION FOR USE: "ENDOGAIN GEL IS INDICATED FOR USE IN CORONALLY POSITIONED FLAP PROCEDURES FOR THE TREATMENT OF GINGIVAL RECESSION DEFECTS". THE DEVICE, WITH THIS ADDITIONAL INDICATION FOR USE, WILL BE MARKETED UNDER THE TRADE NAME ENDOGAIN GEL.

Current openFDA PMA Record#

Device: EMDOGAIN GEL
Applicant: The Straumann Company
PMA number: P930021
Supplement: S008
Product code: NQA
Generic name: Biologic material, dental
Decision date: 2003-12-02
Decision code: APPR
Date received: 2002-09-13
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF THE FOLLOWING INDICATION FOR USE: "ENDOGAIN GEL IS INDICATED FOR USE IN CORONALLY POSITIONED FLAP PROCEDURES FOR THE TREATMENT OF GINGIVAL RECESSION DEFECTS". THE DEVICE, WITH THIS ADDITIONAL INDICATION FOR USE, WILL BE MARKETED UNDER THE TRADE NAME ENDOGAIN GEL.