POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)
FDA premarket approval P850059/S024 · decided 2003-08-13
Approval details
- PMA number
- P850059
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb Surgical, Inc.
- Date received
- 2003-06-11
- Decision date
- 2003-08-13
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS. PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
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