EMODOGAIN
FDA premarket approval P930021/S010 · decided 2007-11-28
Approval details
- PMA number
- P930021
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EMODOGAIN
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2007-10-09
- Decision date
- 2007-11-28
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- APPROVAL FOR TWO MODIFICATIONS TO THE DEVICE INSTRUCTIONS FOR USE: 1) A MODIFICATION OF THE DESCRIPTION OF EMODOGAIN, AND 2) A RESTRICTION OF THE RECOMMENDATION TO THE USE OF PREFGEL TOOTH CONDITIONER.
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