O-PERM F60 RGP CONTACT LENS ADD FINISH LABS

FDA Premarket Approval P890046 S020

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 ADD FINISH LABS
Generic NameLens, Contact (other Material) - Daily
ApplicantOPTICAL POLYMER RESEARCH, INC.
Date Received1993-05-21
Decision Date1993-09-20
PMAP890046
SupplementS020
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
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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