SHELLGEL SODIUM HYALURONATE
FDA premarket approval P000046/S011 · decided 2005-08-03
Approval details
- PMA number
- P000046
- Supplement
- S011
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SHELLGEL SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2005-07-07
- Decision date
- 2005-08-03
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR THE CHANGE IN LABELING TO INCLUDE CANNULA ASSEMBLY INSTRUCTIONS AND FOUR ADDITION LANGUAGES.
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