PARAPERM E.W. (PASIFOCON C) RGP GRAY TINT

FDA Premarket Approval P850038 S018

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

DevicePARAPERM E.W. (PASIFOCON C) RGP GRAY TINT
Generic NameLens, Contact (other Material) - Daily
ApplicantPARAGON OPTICAL CO.
Date Received1992-02-11
Decision Date1992-06-12
PMAP850038
SupplementS018
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address PARAGON OPTICAL CO. 947 East Impala Ave. mesa, AZ 85204

Supplemental Filings

Supplement NumberDateSupplement Type
P850038Original Filing
S023 1993-11-12 Normal 180 Day Track
S022 1993-11-12 Normal 180 Day Track
S021 1993-03-24 Normal 180 Day Track
S020 1992-10-20 Normal 180 Day Track
S019 1992-02-20 Normal 180 Day Track
S018 1992-02-11 Normal 180 Day Track
S017 1992-01-27 30-Day Supplement
S016 1991-07-31 Normal 180 Day Track
S015 1990-12-06 30-Day Supplement
S014 1990-10-05 Normal 180 Day Track
S013 1990-06-20 30-Day Supplement
S012 1990-04-18 Normal 180 Day Track
S011 1990-03-14 30-Day Supplement
S010 1990-02-12 Normal 180 Day Track
S009 1989-10-11 Normal 180 Day Track
S008 1989-08-02 Normal 180 Day Track
S007 1989-05-15 Normal 180 Day Track
S006 1989-04-12 Normal 180 Day Track
S005 1989-01-18 Normal 180 Day Track
S004
S003 1987-10-08 Normal 180 Day Track
S002
S001 1987-09-17 Normal 180 Day Track

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