FLEXLENS

FDA Premarket Approval N17976 S002

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

DeviceFLEXLENS
Generic NameLenses, Soft Contact, Daily Wear
ApplicantPARAGON VISION SCIENCES
Date Received1982-06-03
Decision Date1982-12-02
PMAN17976
SupplementS002
Product CodeLPL 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address PARAGON VISION SCIENCES 947 East Impala Ave. mesa, AZ 85204

Supplemental Filings

Supplement NumberDateSupplement Type
N17976Original Filing
S010 1990-02-09 Normal 180 Day Track
S009
S008 1989-06-16 Normal 180 Day Track
S007
S006
S005 1987-10-02 Normal 180 Day Track
S004 1987-09-24 Normal 180 Day Track
S003 1984-04-27
S002 1982-06-03
S001 1980-05-19

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