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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 PMA to get an up-to-date view of this device.
 
Trade NameMENTOR POLYTEF PASTE /FOR INJECTION
Classification Namepaste, injectable for vocal cord augmentation
ApplicantMENTOR CORP.
PMA NumberN16420
Supplement NumberS006
Date Received10/26/2001
Decision Date11/21/2001
Product Code
LTG
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for relocation of the formulation of the bulk paste and the equipment and processes associated with compounding to mentor, mineapolis, minnisota.
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