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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP990023
Supplement NumberS013
Date Received04/23/2015
Decision Date02/18/2016
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an alternate packaging configuration (syringe, rubber tip cap, pouch), change in the release specification for pH, and change in the release and stability specification for osmolality.
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