SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)
FDA premarket approval P960028/S023 · decided 2007-08-30
Approval details
- PMA number
- P960028
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOFT ACRYLIC INTRAOCULAR LENSES (IOLS)
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2007-08-09
- Decision date
- 2007-08-30
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ADDITION OF AN ALTERNATE CLEANING SOLVENT, LIQUI-NOX, FOR THE 3-PIECE SOFT ACRYLIC INTRAOCULAR LENSES (IOLS) MANUFACTURED AT THE AMO FACILITY IN ANASCO, PUERTO RICO.
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