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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(R) OPHTHALMIC VISCOSURGICAL DEVICE
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP990023
Supplement NumberS016
Date Received06/17/2016
Decision Date09/09/2016
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to replace the current product release intravitreal test with the inflammatory release assay (IRA) product release test.
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