PARAPERM O2 CONTACT LENS

Lens, Contact (polymethylmethacrylate)

FDA Premarket Approval P820063 S005

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 O2 CONTACT LENS
Classification NameLens, Contact (polymethylmethacrylate)
Generic NameLens, Contact (polymethylmethacrylate)
ApplicantPARAGON OPTICAL CO.
Date Received1984-03-13
Decision Date1984-06-04
PMAP820063
SupplementS005
Product CodeHPX
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address PARAGON OPTICAL CO. 947 East Impala Ave. mesa, AZ 85204

Supplemental Filings

Supplement NumberDateSupplement Type
P820063Original Filing
S055 1993-11-12 Normal 180 Day Track
S054 1993-11-12 Normal 180 Day Track
S053 1993-03-24 Normal 180 Day Track
S052 1992-02-20 Normal 180 Day Track
S051 1992-02-11 Normal 180 Day Track
S050 1992-01-27 30-Day Supplement
S049 1991-07-31 Normal 180 Day Track
S048 1990-12-06 30-Day Supplement
S047 1990-10-05 Normal 180 Day Track
S046 1990-06-20 30-Day Supplement
S045 1990-04-18 30-Day Supplement
S044 1990-03-14 30-Day Supplement
S043 1990-02-12 Normal 180 Day Track
S042 1989-10-11 Normal 180 Day Track
S041 1989-08-02 Normal 180 Day Track
S040 1989-05-15 Normal 180 Day Track
S039 1989-04-12 Normal 180 Day Track
S038 1989-01-18 Normal 180 Day Track
S037 1988-11-09 30-Day Supplement
S036 1988-06-10 30-Day Supplement
S035 1988-05-09 30-Day Supplement
S034
S033
S032 1988-04-04 30-Day Supplement
S031
S030 1988-03-07 Normal 180 Day Track
S029
S028 1988-01-11 30-Day Supplement
S027
S026
S025 1987-10-08 Normal 180 Day Track
S024 1987-10-08 Normal 180 Day Track
S023
S022 1987-09-17 Normal 180 Day Track
S021
S020 1987-08-25 30-Day Supplement
S019 1987-06-04 30-Day Supplement
S018 1987-05-22 30-Day Supplement
S017 1987-04-09 30-Day Supplement
S016 1986-06-09 Normal 180 Day Track
S015 1986-06-09 Normal 180 Day Track
S014 1985-04-17
S013 1985-02-08
S012 1985-01-31
S011 1984-12-12
S010 1984-07-20
S009 1984-07-18
S008 1984-06-01
S007 1984-06-04 Normal 180 Day Track
S006 1984-03-30
S005 1984-03-13
S004 1984-03-12
S003
S002 1983-11-04
S001 1983-11-29

NIH GUDID Devices

Device IDPMASupp
B22202 P820063 001

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