STRAUMANN EMDOGAIN(R)
FDA premarket approval P930021/S016 · decided 2017-03-28
Approval details
- PMA number
- P930021
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STRAUMANN EMDOGAIN(R)
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2016-04-06
- Decision date
- 2017-03-28
- Days to decision
- 356 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for 1) adding an alternate glass syringe supplier (Design Change); 2) adding an alternate tamper-evident luer cap design (Design Change); 3) adding an alternate cavity design of the thermoformed tray; part of the secondary sterile barrier packaging (Design Change); 4) adding an alternate supplier of the Tyvek 1073B lid stock which includes a change in adhesive coating; part of the secondary sterile barrier packaging (Design Change); in addition, addressing the change to Transition Tyvek
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