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.
Response to fda's letter of april 28, 1995, re:your 1992 and 1993 annual reports & requested tier a approval for mdls:gl55a-ouv, gl55b-ouv,ps40d-ouv,ps60c-ouv,pb61b-ouv,pb07c-ouv & lp57l-ouv ultraviolet-absorbing posterior chamber iols
Device | MODIFIED J & C LOOP MODEL PA36 |
Classification Name | Intraocular Lens |
Generic Name | Intraocular Lens |
Applicant | EYEKON MEDICAL, INC. |
Date Received | 1995-05-26 |
Decision Date | 1995-08-24 |
PMA | P880072 |
Supplement | S030 |
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 |