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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameAscension PIP
Classification Namehigh demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis
Generic Namehigh demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis
Applicant
Smith & Nephew, Inc.
7135 goodlett farms pkwy.
cordova, TN 38016
HDE NumberH010005
Supplement NumberS010
Date Received01/05/2024
Decision Date03/20/2024
Product Code
OMX[ Registered Establishments with OMX ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval to add mr conditional labeling.
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