|
Device | CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS) |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place Santa Ana, CA 92705 |
PMA Number | P880070 |
Supplement Number | S011 |
Date Received | 01/03/2005 |
Decision Date | 02/04/2005 |
Withdrawal Date
|
10/04/2010 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MODIFY THE "INDICATIONS" STATEMENTS FOR ALL LEGALLY MARKETED IOLS UNDER THE ABOVE REFERENCED PMAS TO REFLECT ADULTS AS OPPOSED TO ADULTS OLDER THAN 60 YEARS OF AGE. |