HYMOVIS® (High Molecular Weight Viscoelastic Hyaluronan)
FDA premarket approval P150010/S004 · decided 2024-10-16
Approval details
- PMA number
- P150010
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYMOVIS® (High Molecular Weight Viscoelastic Hyaluronan)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Fidia Farmaceutici
- Date received
- 2024-09-20
- Decision date
- 2024-10-16
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- Statement
- Change to introduce an additional new filling and stoppering machine
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.