MODEL 13060 UV ABSORBING POSTERIOR CHAMBER LENSES

FDA Premarket Approval P880082 S008

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

DeviceMODEL 13060 UV ABSORBING POSTERIOR CHAMBER LENSES
Generic NameIntraocular Lens
ApplicantEYETECH, LLC.
Date Received1990-04-26
Decision Date1990-06-28
PMAP880082
SupplementS008
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address EYETECH, LLC. 7016 6th St. North oakdale, MN 55128

Supplemental Filings

Supplement NumberDateSupplement Type
P880082Original Filing
S018 1995-06-14 Normal 180 Day Track
S017 1994-02-03 Normal 180 Day Track
S016
S015
S014 1992-03-05 Normal 180 Day Track
S013 1991-05-24 Normal 180 Day Track
S012 1991-05-01 Normal 180 Day Track
S011 1991-01-09 Normal 180 Day Track
S010
S009 1990-11-21 Normal 180 Day Track
S008 1990-04-26 Normal 180 Day Track
S007 1990-04-26 Normal 180 Day Track
S006
S005 1990-04-26 Normal 180 Day Track
S004
S003 1989-11-24 Normal 180 Day Track
S002 1989-05-30 Normal 180 Day Track
S001

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