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 | VALIDATION/GETINGE ETHYLENE OXIDE STERILIZER |
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 | S003 |
Date Received | 08/09/1991 |
Decision Date | 08/27/1991 |
Withdrawal Date
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10/04/2010 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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