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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantEYEKON MEDICAL, INC.
2451 ENTERPRISE RD.
CLEARWATER, FL 33763
PMA NumberP880072
Supplement NumberS012
Date Received01/03/1990
Decision Date02/22/1990
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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