ORTHOVISC SODIUM HYALURONATE
FDA premarket approval P030019/S006 · decided 2004-12-28
Approval details
- PMA number
- P030019
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORTHOVISC SODIUM HYALURONATE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2004-07-01
- Decision date
- 2004-12-28
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL TO MODIFY THE LABELING TO INCLUDE SAFETY INFORMATION CONCERNING A REPEAT COURSE OF TREATMENT OF ORTHOVISC.
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