BIORA EMDOGAIN(R)
FDA premarket approval P930021/S001 · decided 1999-05-18
Approval details
- PMA number
- P930021
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIORA EMDOGAIN(R)
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 1998-01-05
- Decision date
- 1999-05-18
- Days to decision
- 498 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for manufacturing and packaging changes for EMDOGAIN(R).
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