ARRAY 2 MODEL SA44 MULTIFOCAL INTRAOCULAR LENS (IOL)
FDA premarket approval P960028/S009 · decided 2003-08-29
Approval details
- PMA number
- P960028
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ARRAY 2 MODEL SA44 MULTIFOCAL INTRAOCULAR LENS (IOL)
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2003-06-02
- Decision date
- 2003-08-29
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR EXTENDING THE POWER RANGE OF THE ARRAY 2 MODEL SA44 MULTIFOCAL IOL UP TO 35 DIOPTERS.
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