EMDOGAIN GEL
FDA premarket approval P930021/S008 · decided 2003-12-02
Approval details
- PMA number
- P930021
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EMDOGAIN GEL
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2002-09-13
- Decision date
- 2003-12-02
- Days to decision
- 445 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- 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.
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