PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
FDA premarket approval P890047/S014 · decided 2002-03-25
Approval details
- PMA number
- P890047
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Research, Ltd.
- Date received
- 2002-02-20
- Decision date
- 2002-03-25
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR ADDING SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO ENHANCE THE SAFE USE OF THE DEVICE.
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