GELSYN-3
FDA premarket approval P110005/S004 · decided 2020-07-10
Approval details
- PMA number
- P110005
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GELSYN-3
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ibsa Institut Biochimique SA
- Date received
- 2020-06-29
- Decision date
- 2020-07-10
- Days to decision
- 11 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lugano Ticino
- Statement
- Approval for inclusion of the routine use of bioindicators to monitor efficacy of the sterilization cycle for every batch of GELSYN-3.
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