SYNOJOYNT
FDA premarket approval P170016/S001 · decided 2025-12-23
Approval details
- PMA number
- P170016
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNOJOYNT
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Mesoblast
- Date received
- 2025-10-31
- Decision date
- 2025-12-23
- Days to decision
- 53 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Melbourne
- Statement
- Approval for the replacement and relocation of the blistering and labeling equipment and minor change to process and size of label.
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