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 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.
 
DeviceCEEON HSM UV LIGHT ABSORBING PMMA ANTERIOR CHAMBER IOLS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantABBOTT MEDICAL OPTICS INC
1700 E. St. Andrew Place
Santa Ana, CA 92705
PMA NumberP880070
Supplement NumberS012
Date Received04/12/2007
Decision Date05/08/2007
Withdrawal Date 10/04/2010
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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.
-
-