MODELS PCUB-32D0 AND PCUB-53D0

Intraocular Lens

FDA Premarket Approval P830033 S023

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

DeviceMODELS PCUB-32D0 AND PCUB-53D0
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantADVANCED VISION SCIENCE
Date Received1990-10-10
Decision Date1991-05-28
PMAP830033
SupplementS023
Product CodeHQL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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

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