ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P930014/S004 · decided 1997-04-22
Approval details
- PMA number
- P930014
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1996-10-24
- Decision date
- 1997-04-22
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR LABELING CHANGES FOR THE ACRYSOF(R) MOLDED ACRYLIC IOLS.
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