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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.
 
DeviceGEL-ONE
Generic NameAcid, hyaluronic, intraarticular
ApplicantSeikagaku Corp.
6-1, Marunouchi 1-Chome,
Chiyoda-Ku
Tokyo 100-0005
PMA NumberP080020
Supplement NumberS021
Date Received06/30/2016
Decision Date07/25/2016
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Update the application software for the existing intrinsic viscosity measuring system used for the manufacture of Gel-One.
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