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 | TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS |
Generic Name | Lens, Contact (other Material) - Daily |
Applicant | RAND SCIENTIFIC CORP. |
Date Received | 1990-12-05 |
Decision Date | 1990-12-19 |
PMA | P890044 |
Supplement | S010 |
Product Code | HQD |
Advisory Committee | Ophthalmic |
Supplement Type | 30-Day Supplement |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | RAND SCIENTIFIC CORP. 4135 Northgate Blvd., Suite 9 sacramento, CA 95834 |
Supplement Number | Date | Supplement Type |
---|---|---|
P890044 | Original Filing | |
S027 | 1993-12-21 | Normal 180 Day Track |
S026 | 1993-04-29 | Normal 180 Day Track |
S025 | 1993-01-21 | Normal 180 Day Track |
S024 | 1992-12-15 | Normal 180 Day Track |
S023 | 1992-08-07 | Normal 180 Day Track |
S022 | 1992-07-10 | Normal 180 Day Track |
S021 | 1992-05-06 | Normal 180 Day Track |
S020 | 1992-03-24 | Normal 180 Day Track |
S019 | 1992-01-15 | Normal 180 Day Track |
S018 | 1991-11-21 | Normal 180 Day Track |
S017 | 1991-09-27 | Normal 180 Day Track |
S016 | 1991-08-22 | Normal 180 Day Track |
S015 | 1991-06-20 | Normal 180 Day Track |
S014 | 1991-05-24 | Normal 180 Day Track |
S013 | 1991-04-30 | Normal 180 Day Track |
S012 | 1991-02-15 | Normal 180 Day Track |
S011 | 1991-02-13 | Normal 180 Day Track |
S010 | 1990-12-05 | 30-Day Supplement |
S009 | 1990-09-20 | 30-Day Supplement |
S008 | 1990-08-09 | 30-Day Supplement |
S007 | 1990-07-16 | Normal 180 Day Track |
S006 | 1990-06-26 | Normal 180 Day Track |
S005 | 1990-06-14 | Special (immediate Track) |
S004 | 1990-06-04 | Normal 180 Day Track |
S003 | 1990-05-16 | Normal 180 Day Track |
S002 | 1990-03-29 | Normal 180 Day Track |
S001 | 1990-03-29 | Normal 180 Day Track |