Gelsyn-3
FDA premarket approval P110005/S014 · decided 2024-01-11
Approval details
- PMA number
- P110005
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Gelsyn-3
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ibsa Institut Biochimique SA
- Date received
- 2023-12-12
- Decision date
- 2024-01-11
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lugano Ticino
- Statement
- Approval for revisions to symbols utilized in the product labeling including the Product Information document, the needle label, and the product carton box label.
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