ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P960028/S015 · decided 2006-10-20
Approval details
- PMA number
- P960028
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2006-09-19
- Decision date
- 2006-10-20
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE TO AN AUTOMATIC CORING FIXTURE FOR SILICONE INTRAOCULAR LENS LOOP INSERTION.
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