STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS
FDA premarket approval P000046/S007 · decided 2003-03-12
Approval details
- PMA number
- P000046
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2002-11-27
- Decision date
- 2003-03-12
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR USE OF AN ALTERNATE RAW MATERIAL SOURCE.
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