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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 NumberS019
Date Received02/24/2016
Decision Date03/22/2016
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  
Sharing the facility and equipment used to manufacture Gel-One for the purpose of manufacturing a raw material for other products.
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