STAARVISC II,SHELLGEL AND COEASE VISCOELASTICS
FDA premarket approval P000046/S004 · decided 2002-12-03
Approval details
- PMA number
- P000046
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAARVISC II,SHELLGEL AND COEASE VISCOELASTICS
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2002-05-21
- Decision date
- 2002-12-03
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR A BUFFERED FORMULATION (PH 6.8 - 7.6) FOR STAARVISC II, SHELLGEL, AND COEASE VISCOELASTICS.
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