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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 NumberS053
Date Received12/19/2024
Decision Date01/17/2025
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  
The sharing of the existing h-HAD (Gel-One intermediate) manufacturing equipment in Preparation Building-1 in the SKK Takahagi Plant currently used to manufacture Hyaluronic Acid extracted from chicken combs (existing h-Had) along with h-HAD made from Hyaluronic Acid extracted from bacterial fermentation (FHA-h-HAD). The existing validated cleaning method will be used for the shared equipment to assure the cleanliness and minimize risks of cross-contamination of FHA-h-HAD to the existing h-HAD production.
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