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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 NumberS035
Date Received08/01/2019
Decision Date10/30/2019
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change to the design of the Finger Grip of the Gel-One container closure system.
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