HYMOVIS
FDA premarket approval P150010/S001 · decided 2016-11-22
Approval details
- PMA number
- P150010
- Supplement
- S001
- 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
- 2016-10-24
- Decision date
- 2016-11-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Abano Terme
- Statement
- Manufacturing process change to preparation of the principal bulk component.
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