Calcivis Imaging System
FDA premarket approval P170029/S001 · decided 2023-03-23
Approval details
- PMA number
- P170029
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Calcivis Imaging System
- Generic name
- Caries detection product with drug or biologic
- Applicant
- Calcivis Limited
- Date received
- 2023-03-21
- Decision date
- 2023-03-23
- Days to decision
- 2 days
- Decision code
- OK30
- Product code
- QJX
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Edinburgh
- Statement
- Replace the drug substance manufacturing wash step buffer component of Triton X-100 with Ecosurf SA-9 at the 3P Biopharmaceuticals facility located in Navarra, Spain.
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