TriVisc
FDA premarket approval P160057/S001 · decided 2020-06-07
Approval details
- PMA number
- P160057
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TriVisc
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Channel-Markers Medical, LLC
- Date received
- 2020-05-08
- Decision date
- 2020-06-07
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- Approval for revision of the instructions for administration of TriVisc to help prevent any leakage of the product during administration.
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