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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(R) SODIUM HYALURONATE
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantPHARMACIA, INC.
PMA NumberP810031
Supplement NumberS022
Date Received09/20/1999
Decision Date12/21/1999
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the final product release testing requirements for the family of healon(r) sodium hyaluronate viscoelastic products.
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