SAUFLON(R) PW (LIDOFILCON B)

FDA Premarket Approval P790020 S035

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

DeviceSAUFLON(R) PW (LIDOFILCON B)
Generic NameLenses, Soft Contact, Extended Wear
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1987-01-20
Decision Date1987-10-07
PMAP790020
SupplementS035
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 1700 East St. Andrew Pl. santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P790020Original Filing
S059 1998-10-13 Real-time Process
S058 1998-06-25 30-day Notice
S057
S056 1995-03-27 Normal 180 Day Track
S055
S054 1993-11-09 Normal 180 Day Track
S053 1991-04-17 Normal 180 Day Track
S052
S051 1989-07-21 Normal 180 Day Track
S050 1989-07-19 Normal 180 Day Track
S049 1989-06-19 Normal 180 Day Track
S048
S047 1989-05-16 Normal 180 Day Track
S046 1989-04-12 Normal 180 Day Track
S045
S044 1988-11-09 Normal 180 Day Track
S043 1988-11-09 Normal 180 Day Track
S042 1988-05-26 Panel Track
S041 1988-05-19 Normal 180 Day Track
S040 1988-04-27 Special (immediate Track)
S039 1988-03-29 Normal 180 Day Track
S038 1988-03-14 Normal 180 Day Track
S037 1987-07-02 Normal 180 Day Track
S036 1987-02-17 30-Day Supplement
S035 1987-01-20 Normal 180 Day Track
S034 1986-04-02
S033 1985-11-25
S032 1985-09-06
S031 1985-03-25
S030 1984-10-01
S029 1984-07-02
S028 1984-06-26
S027 1984-05-30
S026
S025 1984-05-17
S024 1984-05-15
S023 1984-02-06
S022 1984-01-11
S021 1984-01-10
S020
S019 1983-11-30
S018 1983-11-23
S017 1983-10-06
S016
S015 1983-09-09
S014
S013 1983-07-01
S012 1983-06-08
S011 1983-06-08
S010 1982-06-15
S009 1982-09-29
S008 1982-08-26
S007
S006 1982-05-18
S005 1982-05-03
S004 1981-12-04
S003 1981-09-21
S002 1981-09-01
S001 1980-05-02

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