DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACKAGING CONFIGURATION ONLY)
FDA premarket approval P890047/S046 · decided 2015-06-02
Approval details
- PMA number
- P890047
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACKAGING CONFIGURATION ONLY)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Research, Ltd.
- Date received
- 2015-05-13
- Decision date
- 2015-06-02
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- REPLACE THE CURRENTLY USED ASSAY AND IDENTIFICATION TECHNIQUES WITH AN ALTERNATE METHOD WHICH WILL IDENTIFY AND ASSAY SODIUM HYALURONATE IN YOUR PROVISC® AND DUOVISC® OPHTHALMIC VISCOSURGICAL DEVICES (OVD).
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