HYMOVIS®
FDA premarket approval P150010/S003 · decided 2024-06-28
Approval details
- PMA number
- P150010
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYMOVIS®
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Fidia Farmaceutici
- Date received
- 2024-05-31
- Decision date
- 2024-06-28
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- Statement
- Change to introduce a new superheated water autoclave for the terminal moist-heat sterilization process of the pre-filled syringes
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