MODEL UV44B INTRAOCULAR LENS

FDA Premarket Approval P880041 S001

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 UV44B INTRAOCULAR LENS
Generic NameLens, Contact (other Material) - Daily
ApplicantABBOTT MEDICAL OPTICS INC
Date Received1990-03-12
Decision Date1990-05-08
PMAP880041
SupplementS001
Product CodeHQD 
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
P880041Original Filing
S002 1991-08-09 Normal 180 Day Track
S001 1990-03-12 Normal 180 Day Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.