• 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 record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceCEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ABBOTT MEDICAL OPTICS INC
1700 e. st. andrew place
santa ana, CA 92705
PMA NumberP960034
Supplement NumberS002
Date Received04/12/2007
Decision Date05/08/2007
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a second eto sterilizer (gee 6913 ar-1) used in the sterilization of iols manufactured at the amo groningen, netherlands facility.
-
-