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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMENTOR POLYTEF PASTE FOR INJECTION
Classification Namepaste, injectable for vocal cord augmentation
Generic Namementor polytef paste for injection
ApplicantCOLOPLAST CORP.
PMA NumberN16420
Date Received01/20/1972
Decision Date01/20/1972
Withdrawal Date 10/02/2009
Product Code
LTG
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
Supplements: S001 S004 S005 S006 S007 
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