GELSYN-3
FDA premarket approval P110005/S003 · decided 2018-05-07
Approval details
- PMA number
- P110005
- Supplement
- S003
- 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
- 2018-04-09
- Decision date
- 2018-05-07
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lugano Ticino
- Statement
- Approval for a labeling change to the Product Information leaflet for GELSYN-3 for incorporation of additional details in the instructions for removal of the syringe cap, securing of the needle to the syringe, and removal of the needle shield in preparation for injection of the product.
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