EMDOGAIN
FDA premarket approval P930021/S003 · decided 1999-08-24
Approval details
- PMA number
- P930021
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EMDOGAIN
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 1999-05-20
- Decision date
- 1999-08-24
- Days to decision
- 96 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for packaging changes for EMDOGAIN(R). The following packaging changes are now approved: 1) a change in the size of the glass vial in which the EMDOGAIN powder is supplied from 10 ml to 6 ml; 2) a change from a freezer type rubber stopper to an injection type rubber stopper for the vehicle solution vials and 3) availability of 10 mg of the product in addition to the originally approved 30 mg of the product.
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