MODES SI-18B AND SI-18NB ULTRAVIOLET ABSORBINGSILICONE POSTERIOR CHAMBER IOLS
FDA premarket approval P880081/S023 · decided 1997-10-02
Approval details
- PMA number
- P880081
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODES SI-18B AND SI-18NB ULTRAVIOLET ABSORBINGSILICONE POSTERIOR CHAMBER IOLS
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 1997-06-30
- Decision date
- 1997-10-02
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for alternate sterilization parameters for the 100% ethylene oxide (ETO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salinas, Puerto Rico.
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