MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Premarket Approval P880070 S002

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 UV65 ANTERIOR CHAMBER INTRAOCULAR LENS
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantABBOTT MEDICAL OPTICS INC
Date Received1990-03-12
Decision Date1990-05-08
PMAP880070
SupplementS002
Product CodeHQL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P880070Original Filing
S012 2007-04-12 30-day Notice
S011 2005-01-03 Real-time Process
S010 2003-11-07 Real-time Process
S009
S008 1998-06-23 Real-time Process
S007 1996-05-23 Normal 180 Day Track
S006
S005 1992-11-05 Normal 180 Day Track
S004 1992-06-16 Normal 180 Day Track
S003 1991-08-09 Normal 180 Day Track
S002 1990-03-12 Normal 180 Day Track
S001 1989-08-29 Normal 180 Day Track

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