GELSYN-3
FDA premarket approval P110005/S012 · decided 2022-10-07
Approval details
- PMA number
- P110005
- Supplement
- S012
- 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
- 2022-09-08
- Decision date
- 2022-10-07
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lugano Ticino
- Statement
- Approval for revisions to the Adverse Reactions section of the Product Information and Patient Information labeling based on post-market adverse event and safety data collected up to March 2022.
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