ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS
FDA premarket approval P960028/S010 · decided 2003-08-25
Approval details
- PMA number
- P960028
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS
- Generic name
- Lens, multifocal intraocular
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2003-08-06
- Decision date
- 2003-08-25
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO MODIFY THE DIRECTIONS FOR USE TO INCLUDE AN ADDITIONAL PRECAUTION/WARNING STATEMENT REGARDING STORAGE CONDITIONS: "AVOID EXPOSURE TO VOLATILE CHEMICALS."
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