STYLE 17 & 17A POSTERIOR CHAMBER IOLS

Intraocular Lens

FDA Premarket Approval P830033

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

DeviceSTYLE 17 & 17A POSTERIOR CHAMBER IOLS
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantADVANCED VISION SCIENCE
Date Received1983-06-29
Decision Date1985-09-05
Notice Date1985-10-17
PMAP830033
SupplementS
Product CodeHQL
Docket Number85M-0450
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED VISION SCIENCE 5743 Thornwood Dr. goleta, CA 93117

Supplemental Filings

Supplement NumberDateSupplement Type
P830033Original Filing
S027 1994-07-28 Normal 180 Day Track
S026 1994-01-31 Normal 180 Day Track
S025
S024 1991-04-04 Normal 180 Day Track
S023 1990-10-10 Normal 180 Day Track
S022
S021 1990-04-06 Normal 180 Day Track
S020
S019
S018 1989-12-27 Normal 180 Day Track
S017
S016 1988-11-14 Normal 180 Day Track
S015 1988-11-09 Panel Track
S014 1988-09-29 Panel Track
S013 1988-07-12 Normal 180 Day Track
S012 1988-06-06 Normal 180 Day Track
S011
S010 1986-11-13 Normal 180 Day Track
S009 1986-11-10 Normal 180 Day Track
S008 1986-11-04 Normal 180 Day Track
S007 1986-08-29 Normal 180 Day Track
S006 1986-06-09 Normal 180 Day Track
S005 1986-03-28
S004 1986-04-14
S003 1986-04-14
S002 1985-10-16
S001 1983-07-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.