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 models gl65c-ouv and ps50d-ouv as tier a modifications of previously approved medical developmental reasearch, inc. Parent iols
Device | MODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) |
Classification Name | Intraocular Lens |
Generic Name | Intraocular Lens |
Applicant | EYEKON MEDICAL, INC. |
Date Received | 1995-12-05 |
Decision Date | 1996-04-17 |
PMA | P880072 |
Supplement | S040 |
Product Code | HQL |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | EYEKON MEDICAL, INC. 2451 Enterprise Rd. clearwater, FL 33763 |
Supplement Number | Date | Supplement Type |
---|---|---|
P880072 | Original Filing | |
S047 | 1999-02-08 | Normal 180 Day Track |
S046 | ||
S045 | 1996-12-11 | Normal 180 Day Track |
S044 | 1996-10-16 | Normal 180 Day Track |
S043 | ||
S042 | 1996-01-24 | Normal 180 Day Track |
S041 | ||
S040 | 1995-12-05 | Normal 180 Day Track |
S039 | 1995-12-05 | Normal 180 Day Track |
S038 | ||
S037 | 1995-10-17 | Normal 180 Day Track |
S036 | 1995-08-25 | Normal 180 Day Track |
S035 | 1995-07-25 | Normal 180 Day Track |
S034 | 1995-06-28 | Normal 180 Day Track |
S033 | 1995-05-17 | Normal 180 Day Track |
S032 | 1995-05-18 | Normal 180 Day Track |
S031 | ||
S030 | 1995-05-26 | Normal 180 Day Track |
S029 | 1995-05-23 | Normal 180 Day Track |
S028 | 1995-05-19 | Normal 180 Day Track |
S027 | 1995-05-19 | Normal 180 Day Track |
S026 | 1995-05-16 | Normal 180 Day Track |
S025 | ||
S024 | ||
S023 | ||
S022 | ||
S021 | 1992-04-15 | Normal 180 Day Track |
S020 | ||
S019 | 1991-02-19 | Normal 180 Day Track |
S018 | 1990-10-11 | Normal 180 Day Track |
S017 | ||
S016 | 1990-05-15 | Normal 180 Day Track |
S015 | 1990-05-15 | Normal 180 Day Track |
S014 | 1990-05-15 | Normal 180 Day Track |
S013 | ||
S012 | 1990-01-03 | Normal 180 Day Track |
S011 | 1990-01-03 | Normal 180 Day Track |
S010 | 1990-01-03 | Normal 180 Day Track |
S009 | ||
S008 | 1989-11-01 | Normal 180 Day Track |
S007 | 1988-12-19 | Panel Track |
S006 | ||
S005 | 1988-12-13 | Normal 180 Day Track |
S004 | ||
S003 | 1988-12-13 | Normal 180 Day Track |
S002 | ||
S001 | 1988-12-13 | Normal 180 Day Track |