STAARVISC II & SHELLGEL SODIUM HYALURONATE
FDA premarket approval P000046/S017 · decided 2012-01-17
Approval details
- PMA number
- P000046
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAARVISC II & SHELLGEL SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2010-09-30
- Decision date
- 2012-01-17
- Days to decision
- 474 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ANIKA THERAPEUTICS, INC., IN BEDFORD, MASSACHUSETTS.
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