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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 100-0-0005
PMA NumberP080020
Supplement NumberS038
Date Received07/01/2020
Decision Date07/17/2020
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Automation of the existing bacterial endotoxin test process.
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