ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN
FDA premarket approval P030019/S012 · decided 2006-11-08
Approval details
- PMA number
- P030019
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2006-08-09
- Decision date
- 2006-11-08
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR ELIMINATION OF THE SECOND STERILIZATION STEP FROM THE FINAL PACKAGING PROCESS, AND AN UPDATE TO THE PACKAGE LABELING TO REFLECT THIS CHANGE.
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| SCS 17-01 (K190956) | Anika Therapeutics, Inc. | 2020-01-30 |