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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.
 
DeviceMODIFIED J-LOOP POSTERIOR CHAMBER IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantEyekon Medical, Inc.
2451 Enterprise Rd.
Clearwater, FL 33763
PMA NumberP880072
Supplement NumberS036
Date Received08/25/1995
Decision Date02/12/1996
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE CONTRACT STERILIZER, MEDICAL MANUFACTURING CORP., AT 2205 EAST 33RD STREET, ERIE, PA 16510, AND CONVERSION FROM 12/88 ETHYLENE OXIDE (ETO)/FREON TO 100% ETO STERILIZATION
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