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.
Approval for revised labeling (i. E. , package insert, practitioner fitting guide, and separate patient information booklets for lenses prescribed for frequent replacement wear (focus, focus toric, and newvues (vifilcon a) soft (hydrophilic) contact lenses) and disposable wear (newvues (vifilcon a) soft (hydrophilic) contact lenses). Revisions included (1)merging planned replacement and disposable wearing schedules for the lensese into one package insert and directing the package isert to the eyecare practitioner, (2)writing separate patient instructions for lenses prescribed for disposable and frequent replacement wear, (3)updating the professional fitting guide for consistency with other labeling items, and (4)bringing the labeling up-to-date with fda's current recommendations in an effort to increase consumer comprehension and compliance. The revisions do no result in changes in the devices themselves or the indications for use of the devices
Device | FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES |
Generic Name | Lenses, Soft Contact, Extended Wear |
Applicant | Alcon Laboratories, Inc. |
Date Received | 1996-05-10 |
Decision Date | 1996-09-25 |
PMA | P820021 |
Supplement | S029 |
Product Code | LPM |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099 |
Supplement Number | Date | Supplement Type |
---|---|---|
P820021 | Original Filing | |
S036 | 2013-04-10 | 30-day Notice |
S035 | 2012-11-19 | 30-day Notice |
S034 | 2012-07-05 | 30-day Notice |
S033 | 2011-05-09 | 30-day Notice |
S032 | ||
S031 | 2006-08-22 | Real-time Process |
S030 | 2001-10-16 | Normal 180 Day Track |
S029 | 1996-05-10 | Normal 180 Day Track |
S028 | 1995-06-27 | Normal 180 Day Track |
S027 | 1995-05-15 | 30-Day Supplement |
S026 | 1995-02-17 | Special (immediate Track) |
S025 | 1995-01-17 | Normal 180 Day Track |
S024 | 1994-02-02 | Normal 180 Day Track |
S023 | 1991-04-03 | Normal 180 Day Track |
S022 | 1990-10-31 | Normal 180 Day Track |
S021 | 1990-03-28 | Normal 180 Day Track |
S020 | ||
S019 | 1989-11-22 | Normal 180 Day Track |
S018 | 1989-10-10 | Normal 180 Day Track |
S017 | 1989-07-24 | Normal 180 Day Track |
S016 | 1989-03-01 | Normal 180 Day Track |
S015 | 1988-12-21 | Normal 180 Day Track |
S014 | 1988-05-23 | Normal 180 Day Track |
S013 | 1988-04-04 | Normal 180 Day Track |
S012 | 1988-01-12 | Normal 180 Day Track |
S011 | ||
S010 | 1987-07-01 | Normal 180 Day Track |
S009 | 1987-02-02 | Normal 180 Day Track |
S008 | 1986-03-18 | |
S007 | 1986-03-04 | |
S006 | 1986-03-07 | |
S005 | 1986-02-05 | |
S004 | ||
S003 | 1985-01-10 | |
S002 | 1983-05-17 | |
S001 | 1983-06-07 |