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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.
 
Trade NameHEALON D SODIUM HYALURONATE SOLUTION
Classification Nameaid, surgical, viscoelastic
Generic Nameviscoelastic solution
Regulation Number886.4275
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP880031
Supplement NumberS016
Date Received01/13/2009
Decision Date02/18/2009
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the ph product specification range for healon d from 7. 1 ¿ 7. 5 to 6. 8 ¿ 7. 6.
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