Straumann Emdogain
FDA premarket approval P930021/S018 · decided 2018-09-28
Approval details
- PMA number
- P930021
- Supplement
- S018
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Straumann Emdogain
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2017-12-15
- Decision date
- 2018-09-28
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for: 1) Revision of ventilation and implementation of cooling in clean rooms;2) Emdogain bulk tank will be covered by a sterile autoclave bag during storage time between compounding and filling;3) Implementation of heat-sealed autoclave pouch for sterilization and storage of stopper hopper;4) The sterile phase of the P2R2 autoclave program, validated for sterilization of filters and other equipment used for aseptic production, was increased from 20 to 25 min;5) Sampling and weighing met
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