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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 Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
50 technology drive
irvine, CA 92618
PMA NumberP910071
Supplement NumberS006
Date Received01/29/2002
Decision Date12/23/2002
Product Code
LWL[ Registered Establishments with LWL ]
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 the following changes for adato sil-ol 5000 silicone oil: 1) addition of a new primary container closure system (glass syringe); 2) pharm pur gmbh, augsburg, germany, as the site for filling, sterilization, labeling and packaging for adato sil-ol 5000 silicone oil packaged in a syringe; 3) parametric release of the adato sil-ol 5000 silicone oil syringe packaged product in lieu of end product sterility testing; and 4) double pouch packaging for adato sil-ol 5000 silicone oil syringe.