BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS

Lens, Contact (other Material) - Daily

FDA Premarket Approval P860022 S033

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.

Pre-market Approval Supplement Details

DeviceBOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS
Classification NameLens, Contact (other Material) - Daily
Generic NameLens, Contact (other Material) - Daily
ApplicantPOLYMER TECHNOLOGY CORP.
Date Received1991-03-04
Decision Date1991-03-21
PMAP860022
SupplementS033
Product CodeHQD
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address POLYMER TECHNOLOGY CORP. 1400 N. Goodman St. rochester, NY 14692

Supplemental Filings

Supplement NumberDateSupplement Type
P860022Original 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

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