Collamer UV Absorbing Posterior Chamber Intraocular Lens

Intraocular Lens

FDA Premarket Approval P990013 S037

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

Addition of an autoclave for use in the sterilization of the visian implantable collamer lens (icl) and the collamer intraocular lens (ciol) at the monrovia, california facility.

DeviceCollamer UV Absorbing Posterior Chamber Intraocular Lens
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantSTARR SURGICAL CO.
Date Received2017-07-06
Decision Date2017-08-04
PMAP990013
SupplementS037
Product CodeHQL
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
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
P990013Original Filing
S041 2021-06-22 30-day Notice
S040 2020-03-03 30-day Notice
S039 2019-06-27 30-day Notice
S038 2019-04-22 Real-time Process
S037 2017-07-06 30-day Notice
S036 2017-07-03 30-day Notice
S035 2017-05-19 30-day Notice
S034 2017-03-13 30-day Notice
S033 2014-01-13 30-day Notice
S032
S031 2011-03-30 30-day Notice
S030 2010-12-14 30-day Notice
S029 2010-08-17 Special (immediate Track)
S028 2010-07-15 30-day Notice
S027 2010-06-25 30-day Notice
S026 2010-05-17 30-day Notice
S025 2009-02-09 30-day Notice
S024 2008-10-09 30-day Notice
S023 2008-08-04 30-day Notice
S022 2008-07-23 135 Review Track For 30-day Notice
S021 2008-06-06 30-day Notice
S020 2008-05-05 30-day Notice
S019 2008-04-25 30-day Notice
S018 2008-04-02 Normal 180 Day Track
S017 2008-03-28 30-day Notice
S016 2008-03-20 30-day Notice
S015 2008-02-22 30-day Notice
S014 2007-11-29 Real-time Process
S013 2007-05-04 Special (immediate Track)
S012 2007-02-26 30-day Notice
S011 2007-02-26 30-day Notice
S010 2007-02-23 30-day Notice
S009 2007-02-23 135 Review Track For 30-day Notice
S008 2007-02-22 30-day Notice
S007 2007-02-22 30-day Notice
S006 2007-02-22 30-day Notice
S005
S004 2004-05-24 Special (immediate Track)
S003 2001-07-06 30-day Notice
S002
S001 2000-07-24 Normal 180 Day Track

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