ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P960028/S013 · decided 2005-12-21
Approval details
- PMA number
- P960028
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Trade name
- ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2005-06-28
- Decision date
- 2005-12-21
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR MODIFICATION OF THE INDICATION STATEMENT WITH STANDARDIZED LANGUAGE FOR THE MODELS OF THE ARRAY FAMILY OF MULTIFOCAL INTRAOCULAR LENSES (MODELS SA40N, SA40N2, SA40E, AA40E, AA50 AND NXG1). THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARRAY AND ARE INDICATED FOR: THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITHOUT READING ADD AND INC
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