ANTERIOR CHAMBER INTRAOCULAR LENS

FDA Premarket Approval P010027 S003

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 for parameter changes in the sterilization cycle.

DeviceANTERIOR CHAMBER INTRAOCULAR LENS
Generic NameIntraocular Lens
ApplicantAAREN SCIENTIFIC
Date Received2009-10-28
Decision Date2010-03-12
PMAP010027
SupplementS003
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type135 Review Track For 30-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
P010027Original Filing
S005 2012-02-02 30-day Notice
S004 2012-02-02 30-day Notice
S003 2009-10-28 135 Review Track For 30-day Notice
S002 2008-08-13 30-day Notice
S001 2008-08-13 30-day Notice

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