UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Premarket Approval P970034 S011

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

Changes to the tumbling process.

DeviceUV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantAAREN SCIENTIFIC
Date Received2008-08-13
Decision Date2008-09-12
PMAP970034
SupplementS011
Product CodeHQL
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address AAREN SCIENTIFIC 4290 East Brickell St, Bldg A ontario, CA 91761

Supplemental Filings

Supplement NumberDateSupplement Type
P970034Original Filing
S014 2009-10-28 135 Review Track For 30-day Notice
S013
S012 2008-08-13 30-day Notice
S011 2008-08-13 30-day Notice
S010 2007-12-20 135 Review Track For 30-day Notice
S009 2001-04-19 Normal 180 Day Track
S008 2001-03-26 Normal 180 Day Track
S007 2000-07-06 Normal 180 Day Track
S006 2000-04-19 Normal 180 Day Track
S005 2000-02-14 Normal 180 Day Track
S004 2000-02-14 Panel Track
S003 1999-03-23 30-day Notice
S002 1998-12-21 Normal 180 Day Track
S001 1998-10-22 30-day Notice

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