STAARVISC II & SHELLGEL SODIUM HYALURONATE
FDA premarket approval P000046/S018 · decided 2010-12-01
Approval details
- PMA number
- P000046
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAARVISC II & SHELLGEL SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2010-11-03
- Decision date
- 2010-12-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- CHANGE IN RAW MATERIAL SAMPLE PREPARATION FOR ENDOTOXIN TESTING.
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