PERMALENS (PERFILCON A) SOFT HYDROPHILIC CONTACT LENS

FDA Premarket Approval P780010

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DevicePERMALENS (PERFILCON A) SOFT HYDROPHILIC CONTACT LENS
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCOOPERVISION, INC.
Date Received1978-11-14
Decision Date1979-06-11
Notice Date1979-12-28
PMAP780010
SupplementS
Product CodeLPM 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address COOPERVISION, INC. 6150 Stoneridge Mall Road suite 500 pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P780010Original Filing
S022 2001-04-18 Normal 180 Day Track
S021 1999-04-19 Normal 180 Day Track
S020 1998-10-28 Real-time Process
S019 1991-12-05 Normal 180 Day Track
S018 1989-07-24 Normal 180 Day Track
S017 1989-07-24 Normal 180 Day Track
S016 1989-04-12 Normal 180 Day Track
S015 1988-04-28 Special (immediate Track)
S014 1985-07-11
S013 1983-11-18
S012 1983-05-24
S011 1983-05-16
S010 1983-04-18
S009
S008 1980-12-29 Normal 180 Day Track
S007
S006
S005
S004
S003
S002 1979-10-26
S001

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