Acid, Hyaluronic, Intraarticular
Basic Information
- Device Name
- Acid, Hyaluronic, Intraarticular
- Trade Name
- GELSYN-3
- PMA Number
- P110005
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- MOZ
- Generic Name
- Acid, hyaluronic, intraarticular
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 10, 2017
- Date Received
- January 19, 2017
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for revisions to the labeling of GELSYN-3 as follows: 1) Deletion of the statement, The safety and effectiveness of repeat treatment cycles of Gel-Syn have not been established from the Patient Information leaflet and addition of the statement, The effectiveness of repeat treatment cycles of GELSYN-3 has not been established. to the Product Information and Patient Information leaflets; and2) Addition of the statements, Adverse experience data from clinical use does not show an increased safety risk from retreatment with GELSYN-3. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle to the Product Information and Patient Information leaflets.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOZ | Acid, Hyaluronic, Intraarticular | FDA class 3 | Unknown |