EMDOGAIN
FDA premarket approval P930021/S011 · decided 2009-06-19
Approval details
- PMA number
- P930021
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EMDOGAIN
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2008-03-27
- Decision date
- 2009-06-19
- Days to decision
- 449 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- 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
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