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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.
 
DeviceBIOLON
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAltacor Ltd.
Merlin House, Brunel Road
Theale RG7 4
PMA NumberP960011
Supplement NumberS031
Date Received04/04/2019
Decision Date05/01/2019
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Qualification of an additional chamber and use of a modified ethylene oxide sterilization cycle for the BIOLON® Ophthalmic Viscosurgical Device (OVD).
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