LENS PLUS(TM)

Accessories, Soft Lens Products

FDA Premarket Approval P820050 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

DeviceLENS PLUS(TM)
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1984-04-30
Decision Date1985-02-15
PMAP820050
SupplementS005
Product CodeLPN
Advisory CommitteeOphthalmic
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.