Gel-Syn
FDA premarket approval P110005/S001 · decided 2016-05-23
Approval details
- PMA number
- P110005
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Gel-Syn
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ibsa Institut Biochimique SA
- Date received
- 2016-03-25
- Decision date
- 2016-05-23
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lugano Ticino
- Statement
- Approval for the addition of a needle to the Gel-Syn packaging configuration
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