UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S

FDA Premarket Approval P880091 S006

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

Approval to add an alternate vendor for part of your manufacturing process

DeviceUV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S
Generic NameIntraocular Lens
ApplicantSTARR SURGICAL CO.
Date Received1995-12-04
Decision Date1996-07-01
PMAP880091
SupplementS006
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address STARR SURGICAL CO. 1911 Walker Ave. monrovia, CA 91016

Supplemental Filings

Supplement NumberDateSupplement Type
P880091Original Filing
S032 2010-08-17 Special (immediate Track)
S031
S030 2008-01-15 30-day Notice
S029 2008-12-12 30-day Notice
S028 2008-07-23 135 Review Track For 30-day Notice
S027 2008-07-18 30-day Notice
S026 2008-04-16 30-day Notice
S025 2008-04-02 Real-time Process
S024 2007-12-17 30-day Notice
S023 2007-11-09 Real-time Process
S022 2007-04-17 30-day Notice
S021 2007-03-01 30-day Notice
S020 2007-02-26 30-day Notice
S019 2005-09-28 30-day Notice
S018 2005-06-03 30-day Notice
S017 1999-07-30 30-day Notice
S016 1999-01-22 Normal 180 Day Track
S015 1998-09-17 Normal 180 Day Track
S014 1997-12-16 Panel Track
S013
S012 1997-08-19 Normal 180 Day Track
S011 1997-08-14 Normal 180 Day Track
S010 1997-03-26 Real-time Process
S009 1996-05-28 Normal 180 Day Track
S008 1996-04-18 Normal 180 Day Track
S007 1996-03-21 Normal 180 Day Track
S006 1995-12-04 Normal 180 Day Track
S005 1995-10-03 Normal 180 Day Track
S004 1992-12-18 Normal 180 Day Track
S003 1992-06-04 Normal 180 Day Track
S002 1992-04-23 Normal 180 Day Track
S001

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