Straumann Emdogain
FDA premarket approval P930021/S019 · decided 2018-08-14
Approval details
- PMA number
- P930021
- Supplement
- S019
- 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
- 2018-04-13
- Decision date
- 2018-08-14
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Approval for the change made to an original visual inspection room E166. The room was remodeled by means of taking down dividing walls and extended to incorporate existing E143 labeling space to form one large labeling room. Both rooms are considered to be clean rooms.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.