PMA P960028S013
- Device
- ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S013
- Product code
- MFK
- Decision date
- 2005-12-21
- Generic name
- Lens, multifocal intraocular
- Approval order 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 INCREASED SPECTACLE, INDEPENDENCE.
Current openFDA PMA Record#
- Device
- ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S013
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2005-12-21
- Decision code
- APPR
- Date received
- 2005-06-28
- Supplement type
- Normal 180 Day Track
- Approval order 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 INCREASED SPECTACLE, INDEPENDENCE.