GELSYN-3
FDA premarket approval P110005/S002 · decided 2017-03-10
Approval details
- PMA number
- P110005
- Supplement
- S002
- Supplement type
- Normal 180 Day 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
- 2017-01-19
- Decision date
- 2017-03-10
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lugano Ticino
- Statement
- Approval for revisions to the labeling of GELSYN-3 as follows: 1) Deletion of the statement, The safety and effectiveness of repeat treatment cycles of Gel-Syn have not been established from the Patient Information leaflet and addition of the statement, The effectiveness of repeat treatment cycles of GELSYN-3 has not been established. to the Product Information and Patient Information leaflets; and2) Addition of the statements, Adverse experience data from clinical use does not show an increased
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