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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceMODIFIED J & C LOOP MODEL PA36 POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
EYEKON MEDICAL, INC.
2451 enterprise rd.
clearwater, FL 33763
PMA NumberP880072
Supplement NumberS037
Date Received10/17/1995
Decision Date11/01/1995
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for tier a posterior chamber intraocular lens model pa84b-ouv.
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