CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A
FDA premarket approval P990080/S044 · decided 2016-11-21
Approval details
- PMA number
- P990080
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2016-11-02
- Decision date
- 2016-11-21
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Addition of a second purified water distribution loop (Loop 2) to the existing purified water system.
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