FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A ,913A & TECNIS Z9000, Z9001
FDA premarket approval P990080/S015 · decided 2007-01-16
Approval details
- PMA number
- P990080
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A ,913A & TECNIS Z9000, Z9001
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2006-12-18
- Decision date
- 2007-01-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE TO A FIXTURE USED IN THE SHEET CASTING PROCESS FOR THE FOLDABLE AND SOFT ACRYLIC INTRAOCULAR LENSES.
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