Staumann Emdogain
FDA premarket approval P930021/S025 · decided 2019-09-03
Approval details
- PMA number
- P930021
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Staumann Emdogain
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2019-08-09
- Decision date
- 2019-09-03
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- Statement
- Updating the environmental monitoring program; relocating the doors to a refrigerator and freezer (moved from one wall to another); and introducing a cutting tool and changed tolerance for seal strength test strips
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.