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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 Namepaste, injectable for vocal cord augmentation
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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