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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMENTOR POLYTEF PASTE FOR INJECTION
Classification Namepaste, injectable for vocal cord augmentation
Generic Namepaste, injectable for vocal cord augmentation
Applicant
COLOPLAST CORP.
1601 west river road north
minneapolis, MN 55411
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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