O-PERM F60 RGP CONTACT LENS

FDA Premarket Approval P890046 S024

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

DeviceO-PERM F60 RGP CONTACT LENS
Generic NameLens, Contact (other Material) - Daily
ApplicantOPTICAL POLYMER RESEARCH, INC.
Date Received1993-10-18
Decision Date1993-11-04
PMAP890046
SupplementS024
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address OPTICAL POLYMER RESEARCH, INC. 5921 N.e. 38th St. gainesville, FL 32609

Supplemental Filings

Supplement NumberDateSupplement Type
P890046Original 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

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