DUOVISC VISCOELASTIC SYSTEM
FDA premarket approval P890047/S007 · decided 1995-08-02
Approval details
- PMA number
- P890047
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DUOVISC VISCOELASTIC SYSTEM
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Research, Ltd.
- Date received
- 1995-05-30
- Decision date
- 1995-08-02
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A MODIFICATION TO THE DUOVISC PACKAGE INSERT TO ALLOW FOR THE USE OF BOTH DEVICES IN A SINGLE OPHTHALMIC PROCEDURE
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