PMA P150010S003
- Device
- HYMOVIS®
- Applicant
- Fidia Farmaceutici
- PMA number
- P150010
- Supplement
- S003
- Product code
- MOZ
- Decision date
- 2024-06-28
- Classification
- Orthopedic
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Change to introduce a new superheated water autoclave for the terminal moist-heat sterilization process of the pre-filled syringes
Current openFDA PMA Record#
- Device
- HYMOVIS®
- Applicant
- Fidia Farmaceutici
- PMA number
- P150010
- Supplement
- S003
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2024-06-28
- Decision code
- OK30
- Date received
- 2024-05-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to introduce a new superheated water autoclave for the terminal moist-heat sterilization process of the pre-filled syringes