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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 Namefinger semi-constrained pyrolytic carbon uncemented prosthesis
Generic Namefinger semi-constrained pyrolytic carbon uncemented prosthesis
Applicant
Smith & Nephew, Inc.
7135 goodlett farms pkwy.
cordova, TN 38016
HDE NumberH010005
Supplement NumberS006
Date Received08/23/2010
Decision Date11/08/2010
Product Code
NEG[ Registered Establishments with NEG ]
Notice Date 11/08/2010
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for revisions to the physician and patient labeling.
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