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.
Device | O-PERM F60 RGP CONTACT LENS |
Generic Name | Lens, Contact (other Material) - Daily |
Applicant | OPTICAL POLYMER RESEARCH, INC. |
Date Received | 1991-11-25 |
Decision Date | 1991-12-18 |
PMA | P890046 |
Supplement | S014 |
Product Code | HQD |
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 | OPTICAL POLYMER RESEARCH, INC. 5921 N.e. 38th St. gainesville, FL 32609 |
Supplement Number | Date | Supplement Type |
---|---|---|
P890046 | Original Filing | |
S027 | 1994-02-10 | Normal 180 Day Track |
S026 | 1994-02-07 | Normal 180 Day Track |
S025 | 1993-12-13 | Normal 180 Day Track |
S024 | 1993-10-18 | Normal 180 Day Track |
S023 | 1993-08-31 | Normal 180 Day Track |
S022 | 1993-06-29 | Normal 180 Day Track |
S021 | 1993-06-14 | Normal 180 Day Track |
S020 | 1993-05-21 | Normal 180 Day Track |
S019 | 1992-12-14 | Normal 180 Day Track |
S018 | 1992-10-13 | Normal 180 Day Track |
S017 | 1992-06-08 | Normal 180 Day Track |
S016 | 1992-04-20 | Normal 180 Day Track |
S015 | 1992-01-21 | Normal 180 Day Track |
S014 | 1991-11-25 | Normal 180 Day Track |
S013 | 1991-10-16 | Normal 180 Day Track |
S012 | 1991-08-19 | Normal 180 Day Track |
S011 | 1991-06-24 | Normal 180 Day Track |
S010 | 1991-05-20 | Normal 180 Day Track |
S009 | 1991-04-29 | Normal 180 Day Track |
S008 | 1991-04-09 | Normal 180 Day Track |
S007 | 1991-01-29 | 30-Day Supplement |
S006 | 1990-11-08 | 30-Day Supplement |
S005 | 1990-10-17 | Normal 180 Day Track |
S004 | 1990-09-28 | Normal 180 Day Track |
S003 | 1990-08-29 | 30-Day Supplement |
S002 | 1990-08-09 | 30-Day Supplement |
S001 | 1990-07-25 | 30-Day Supplement |