CEEON MODELS 911A AND 913A, TECNIS MODELS Z9000 AND Z9001
FDA premarket approval P990080/S023 · decided 2007-05-08
Approval details
- PMA number
- P990080
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CEEON MODELS 911A AND 913A, TECNIS MODELS Z9000 AND Z9001
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2007-04-12
- Decision date
- 2007-05-08
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ADDITION OF A SECOND ETO STERILIZER (GEE 6913 AR-1) USED IN THE STERILIZATION OF IOLS MANUFACTURED AT THE AMO GRONINGEN, NETHERLANDS FACILITY.
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