GELSYN-3
FDA premarket approval P110005/S013 · decided 2023-03-10
Approval details
- PMA number
- P110005
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GELSYN-3
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ibsa Institut Biochimique SA
- Date received
- 2023-02-10
- Decision date
- 2023-03-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lugano Ticino
- Statement
- Changes to methods for routine sterility and endotoxin monitoring per USP <71> and USP <85>.
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