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 | BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS |
Classification Name | Lens, Contact (other Material) - Daily |
Generic Name | Lens, Contact (other Material) - Daily |
Applicant | POLYMER TECHNOLOGY CORP. |
Date Received | 1990-12-31 |
Decision Date | 1991-02-04 |
PMA | P860022 |
Supplement | S032 |
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 | POLYMER TECHNOLOGY CORP. 1400 N. Goodman St. rochester, NY 14692 |
Supplement Number | Date | Supplement Type |
---|---|---|
P860022 | Original Filing | |
S059 | 2016-06-27 | 30-day Notice |
S058 | 2011-05-31 | 30-day Notice |
S057 | 2008-01-31 | Real-time Process |
S056 | 2006-01-27 | 135 Review Track For 30-day Notice |
S055 | 2003-10-28 | Real-time Process |
S054 | 2002-01-30 | Normal 180 Day Track |
S053 | 2001-09-25 | Normal 180 Day Track |
S052 | 2000-01-05 | 30-Day Supplement |
S051 | 1998-03-12 | 30-Day Supplement |
S050 | 1998-02-20 | 30-Day Supplement |
S049 | 1997-12-22 | Normal 180 Day Track |
S048 | 1997-09-16 | Normal 180 Day Track |
S047 | 1995-05-01 | Special (immediate Track) |
S046 | 1995-04-27 | Special (immediate Track) |
S045 | 1994-01-14 | Normal 180 Day Track |
S044 | 1993-08-02 | Normal 180 Day Track |
S043 | 1993-08-02 | Normal 180 Day Track |
S042 | ||
S041 | 1992-06-30 | Normal 180 Day Track |
S040 | 1992-06-09 | Normal 180 Day Track |
S039 | 1992-03-03 | Normal 180 Day Track |
S038 | 1992-01-16 | Normal 180 Day Track |
S037 | 1992-01-03 | Normal 180 Day Track |
S036 | 1991-11-04 | Normal 180 Day Track |
S035 | 1991-10-29 | Normal 180 Day Track |
S034 | 1991-03-20 | Normal 180 Day Track |
S033 | 1991-03-04 | Normal 180 Day Track |
S032 | 1990-12-31 | 30-Day Supplement |
S031 | 1990-11-08 | Normal 180 Day Track |
S030 | 1990-11-06 | Normal 180 Day Track |
S029 | 1990-10-01 | Normal 180 Day Track |
S028 | 1990-05-11 | Normal 180 Day Track |
S027 | ||
S026 | 1990-03-16 | 30-Day Supplement |
S025 | 1990-03-12 | 30-Day Supplement |
S024 | 1990-02-07 | Normal 180 Day Track |
S023 | 1989-11-30 | Normal 180 Day Track |
S022 | 1989-11-13 | Normal 180 Day Track |
S021 | 1989-10-31 | Normal 180 Day Track |
S020 | 1989-07-27 | Normal 180 Day Track |
S019 | 1989-07-18 | Normal 180 Day Track |
S018 | 1989-06-23 | Normal 180 Day Track |
S017 | 1989-05-18 | Normal 180 Day Track |
S016 | 1989-05-05 | Normal 180 Day Track |
S015 | ||
S014 | 1989-02-16 | Normal 180 Day Track |
S013 | 1988-12-02 | Normal 180 Day Track |
S012 | 1988-10-27 | Normal 180 Day Track |
S011 | 1988-09-01 | Normal 180 Day Track |
S010 | 1988-08-03 | 30-Day Supplement |
S009 | ||
S008 | 1988-07-19 | 30-Day Supplement |
S007 | 1988-07-01 | Normal 180 Day Track |
S006 | 1988-06-13 | 30-Day Supplement |
S005 | 1988-06-02 | Normal 180 Day Track |
S004 | 1988-06-01 | Normal 180 Day Track |
S003 | 1988-02-26 | Normal 180 Day Track |
S002 | 1988-02-03 | Normal 180 Day Track |
S001 | 1988-01-15 | Normal 180 Day Track |