STAARVISC II SODIUM HYALURONATE AND SHELLGEL SODIUM HYALURONATE
FDA premarket approval P000046/S002 · decided 2002-08-30
Approval details
- PMA number
- P000046
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAARVISC II SODIUM HYALURONATE AND SHELLGEL SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2002-03-18
- Decision date
- 2002-08-30
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR AN ADDITIONAL CLEANROOM AREA.
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