EMDOGAIN GEL
FDA premarket approval P930021/S007 · decided 2003-05-20
Approval details
- PMA number
- P930021
- Supplement
- S007
- 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
- 2002-07-01
- Decision date
- 2003-05-20
- Days to decision
- 323 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- APPROVAL OF THE ADDITIONAL INDICATIONS FOR USE AS AN ADJUNCT TO PERIODONTAL SURGERY FOR MANDIBULAR CLASS II FURCATIONS WITH MINIMAL INTERPROXIMAL BONE LOSS.
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