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 an alternate contract sterilizer, medical manufacturing corp. , at 2205 east 33rd street, erie, pa 16510, and conversion from 12/88 ethylene oxide (eto)/freon to 100% eto sterilization
Device | MODIFIED J-LOOP POSTERIOR CHAMBER IOL |
Classification Name | Intraocular Lens |
Generic Name | Intraocular Lens |
Applicant | EYEKON MEDICAL, INC. |
Date Received | 1995-08-25 |
Decision Date | 1996-02-12 |
PMA | P880072 |
Supplement | S036 |
Product Code | HQL |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
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 |