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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.
Classification Nameintraocular lens
Generic Namemodified j-loop posterior chamber iol
Regulation Number886.3600
ApplicantDGR, INC.
PMA NumberP880072
Supplement NumberS030
Date Received05/26/1995
Decision Date08/24/1995
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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.