COEASE SODIUM HYALURONATE
FDA premarket approval P000046/S003 · decided 2002-05-08
Approval details
- PMA number
- P000046
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COEASE SODIUM HYALURONATE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Anika Therapeutics, Inc.
- Date received
- 2002-04-17
- Decision date
- 2002-05-08
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Beford, MA
- Statement
- APPROVAL FOR A PRIVATE DISTRIBUTOR AGREEMENT WITH ADVANCED MEDICAL OPTICS. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME COEASE SODIUM HYALURONATE AND WILL BE DISTRIBUTED IN VOLUMES OF 0.5 ML AND 0.8 ML.
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