ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRALOCULAR
FDA premarket approval P960028/S005 · decided 1999-12-09
Approval details
- PMA number
- P960028
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRALOCULAR
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 1999-10-21
- Decision date
- 1999-12-09
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for expansion of the diopter range from 10-30D to 6-30D.
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