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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.
 
DeviceOPHTHALMIC VICOSURGICAL DEVICE (OVD)
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
ALCON LABORATORIES
6201 s freeway
ft worth, TX 76134
PMA NumberP840064
Supplement NumberS064
Date Received02/01/2017
Decision Date10/25/2017
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the use of Alcon Ireland Cork (AIC) as an alternative supplier of the cannula component to be used as part of the finished Ophthalmic Viscosurgical Devices (OVDs) at Alcon-Couvreur (Purrs) manufacturing facility.
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