EMDOGAIN GEL
FDA premarket approval P930021/S006 · decided 2003-03-28
Approval details
- PMA number
- P930021
- Supplement
- S006
- 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
- 2002-06-17
- Decision date
- 2003-03-28
- Days to decision
- 284 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- APPROVAL FOR EXTENSION OF THE EXPIRATION DATE ON EMDOGAIN GEL FROM 18 MONTHS TO 24 MONTHS.
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