PMA P960028S009
- Device
- ARRAY 2 MODEL SA44 MULTIFOCAL INTRAOCULAR LENS (IOL)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S009
- Product code
- MFK
- Decision date
- 2003-08-29
- Generic name
- Lens, multifocal intraocular
- Approval order statement
- APPROVAL FOR EXTENDING THE POWER RANGE OF THE ARRAY 2 MODEL SA44 MULTIFOCAL IOL UP TO 35 DIOPTERS.
Current openFDA PMA Record#
- Device
- ARRAY 2 MODEL SA44 MULTIFOCAL INTRAOCULAR LENS (IOL)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P960028
- Supplement
- S009
- Product code
- MFK
- Generic name
- Lens, multifocal intraocular
- Decision date
- 2003-08-29
- Decision code
- APPR
- Date received
- 2003-06-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR EXTENDING THE POWER RANGE OF THE ARRAY 2 MODEL SA44 MULTIFOCAL IOL UP TO 35 DIOPTERS.