Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
1700 E. ST. ANDREW PLACE
P.O. BOX 25162
SANTA ANA, CA 92705-4933
PMA NumberP940007
Date Received02/28/1994
Decision Date07/20/1995
Withdrawal Date 01/22/2008
Product Code HQL 
Docket Number 95m-0395
Notice Date 12/19/1995
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODEL WS-100 PLIOLENS ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS
Supplements:  S001 S002 S004 S005 S006 
-
-