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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 & C LOOP MODEL PA36
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantEyekon Medical, Inc.
2451 Enterprise Rd.
Clearwater, FL 33763
PMA NumberP880072
Supplement NumberS030
Date Received05/26/1995
Decision Date08/24/1995
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
RESPONSE TO FDA'S LETTER OF APRIL 28, 1995, RE:YOUR 1992 AND 1993 ANNUAL REPORTS & REQUESTED TIER A APPROVAL FOR MDLS:GL55A-OUV, GL55B-OUV,PS40D-OUV,PS60C-OUV,PB61B-OUV,PB07C-OUV & LP57L-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER IOLS
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