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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 parkway
cordova, TN 38016
HDE NumberH010005
Supplement NumberS004
Date Received10/23/2007
Decision Date01/03/2008
Product Code
NEG[ Registered Establishments with NEG ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval to add a hydroxyapatite (ha) coating to the stem of the ascension pip proximal and distal components.
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