LENS PLUS(TM)

Accessories, Soft Lens Products

FDA Premarket Approval P820050 S020

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

DeviceLENS PLUS(TM)
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1989-09-29
Decision Date1989-10-24
PMAP820050
SupplementS020
Product CodeLPN
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
P820050Original Filing
S020 1989-09-29 Normal 180 Day Track
S019 1989-01-06 Normal 180 Day Track
S018 1987-10-20 Normal 180 Day Track
S017
S016 1987-03-16 30-Day Supplement
S015 1987-03-03 Normal 180 Day Track
S014 1987-01-29 Normal 180 Day Track
S013 1985-05-24
S012 1985-07-23
S011 1985-04-15
S010 1985-05-16
S009 1985-05-16
S008 1984-09-05
S007 1984-09-05
S006 1984-09-05
S005 1984-04-30
S004 1984-04-30
S003 1984-04-02
S002 1983-10-18
S001 1983-10-18

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