PHACO-FLEX(TM) MODELS SI-18B & SI-18NB IOL
FDA premarket approval P880081/S011 · decided 1994-09-19
Approval details
- PMA number
- P880081
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PHACO-FLEX(TM) MODELS SI-18B & SI-18NB IOL
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 1992-02-04
- Decision date
- 1994-09-19
- Days to decision
- 958 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
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