EMDOGAIN
FDA premarket approval P930021/S004 · decided 2001-01-19
Approval details
- PMA number
- P930021
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EMDOGAIN
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2000-03-09
- Decision date
- 2001-01-19
- Days to decision
- 316 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- APPROVAL TO CHANGE FROM THE EMDOGAIN(R) TWO VIAL SYSTEM TO THE EMOGAIN(R) GEL FILLED STERILE SYRINGES.
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