GELSYN-3
FDA premarket approval P110005/S011 · decided 2022-03-18
Approval details
- PMA number
- P110005
- Supplement
- S011
- 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
- 2022-02-16
- Decision date
- 2022-03-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lugano Ticino
- Statement
- Addition of an alternative filter for bulk solution filtration.
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