EMDOGAIN
FDA premarket approval P930021/S009 · decided 2006-04-24
Approval details
- PMA number
- P930021
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EMDOGAIN
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2006-04-11
- Decision date
- 2006-04-24
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- APPROVAL FOR THE ADDITION OF POST-MARKET EXPERIENCE INFORMATION TO THE WARNING SECTION OF THE EMDOGAIN PACKAGE INSERT.
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