BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (rigid Gas Permeable), Extended Wear

FDA Premarket Approval P860022 S054

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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 only) and specify daily wear for the toric and bifocal designs; b) remove from these product description sections the phrase "without uv" because this option is no longer available; and c) change the color name of the blue lens material from "dark blue" to "electric blue". 4) correct the manufacturer's address. 5) update the wording of the uv warning and clarify the extended wear indication as in the indication stated below. "the boston equalens (itafluorofocon a) rgp contact lens is indicated for daily or extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. The lens is indicated for extended wear for the correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes in powers from -20. 00d to +12. 00d. The lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only. "

DeviceBOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS
Classification NameLens, Contact (rigid Gas Permeable), Extended Wear
Generic NameLens, Contact (rigid Gas Permeable), Extended Wear
ApplicantPOLYMER TECHNOLOGY CORP.
Date Received2002-01-30
Decision Date2002-05-06
PMAP860022
SupplementS054
Product CodeMWL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address POLYMER TECHNOLOGY CORP. 1400 N. Goodman St. rochester, NY 14692

Supplemental Filings

Supplement NumberDateSupplement Type
P860022Original Filing
S059 2016-06-27 30-day Notice
S058 2011-05-31 30-day Notice
S057 2008-01-31 Real-time Process
S056 2006-01-27 135 Review Track For 30-day Notice
S055 2003-10-28 Real-time Process
S054 2002-01-30 Normal 180 Day Track
S053 2001-09-25 Normal 180 Day Track
S052 2000-01-05 30-Day Supplement
S051 1998-03-12 30-Day Supplement
S050 1998-02-20 30-Day Supplement
S049 1997-12-22 Normal 180 Day Track
S048 1997-09-16 Normal 180 Day Track
S047 1995-05-01 Special (immediate Track)
S046 1995-04-27 Special (immediate Track)
S045 1994-01-14 Normal 180 Day Track
S044 1993-08-02 Normal 180 Day Track
S043 1993-08-02 Normal 180 Day Track
S042
S041 1992-06-30 Normal 180 Day Track
S040 1992-06-09 Normal 180 Day Track
S039 1992-03-03 Normal 180 Day Track
S038 1992-01-16 Normal 180 Day Track
S037 1992-01-03 Normal 180 Day Track
S036 1991-11-04 Normal 180 Day Track
S035 1991-10-29 Normal 180 Day Track
S034 1991-03-20 Normal 180 Day Track
S033 1991-03-04 Normal 180 Day Track
S032 1990-12-31 30-Day Supplement
S031 1990-11-08 Normal 180 Day Track
S030 1990-11-06 Normal 180 Day Track
S029 1990-10-01 Normal 180 Day Track
S028 1990-05-11 Normal 180 Day Track
S027
S026 1990-03-16 30-Day Supplement
S025 1990-03-12 30-Day Supplement
S024 1990-02-07 Normal 180 Day Track
S023 1989-11-30 Normal 180 Day Track
S022 1989-11-13 Normal 180 Day Track
S021 1989-10-31 Normal 180 Day Track
S020 1989-07-27 Normal 180 Day Track
S019 1989-07-18 Normal 180 Day Track
S018 1989-06-23 Normal 180 Day Track
S017 1989-05-18 Normal 180 Day Track
S016 1989-05-05 Normal 180 Day Track
S015
S014 1989-02-16 Normal 180 Day Track
S013 1988-12-02 Normal 180 Day Track
S012 1988-10-27 Normal 180 Day Track
S011 1988-09-01 Normal 180 Day Track
S010 1988-08-03 30-Day Supplement
S009
S008 1988-07-19 30-Day Supplement
S007 1988-07-01 Normal 180 Day Track
S006 1988-06-13 30-Day Supplement
S005 1988-06-02 Normal 180 Day Track
S004 1988-06-01 Normal 180 Day Track
S003 1988-02-26 Normal 180 Day Track
S002 1988-02-03 Normal 180 Day Track
S001 1988-01-15 Normal 180 Day Track

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