BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS
FDA premarket approval P860022/S054 · decided 2002-05-06
Approval details
- PMA number
- P860022
- Supplement
- S054
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- Bausch & Lomb
- Date received
- 2002-01-30
- Decision date
- 2002-05-06
- Days to decision
- 96 days
- Decision code
- APPR
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR AN ASPHERIC DESIGN FOR EXTENDED WEAR AND LABELING CHANGES FOR THE DEVICE. REQUESTED LABELING CHANGES INCLUDE: 1) CHANGE FROM THE TITLE "PATIENT INSTRUCTIONS" TO "PATIENT CARE GUIDE". 2) UPDATE THE PRESCRIPTION CAUTION STATEMENT. 3) MODIFY THE PRODUCT DESCRIPTION SECTION OF THE PACKAGE INSERT AND PROFESSIONAL FITTING AND INFORMATION GUIDE AS FOLLOWS: A) ADD THE DESCRIPTIONS FOR BOTH THE ASPHERIC DESIGN (EXTENDED AND DAILY WEAR) AND THE PREVIOUSLY APPROVED BIFOCAL LENS (DAILY WEAR ONL
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