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. |
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Device | CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR 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 | P960034 |
Supplement Number | S002 |
Date Received | 04/12/2007 |
Decision Date | 05/08/2007 |
Withdrawal Date
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10/01/2009 |
Product Code |
HQL |
Advisory Committee |
Neurology |
Supplement Type | 30-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. |
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