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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 NamePOLYTEF PASTE FOR INJECTION
Classification Namepaste, injectable for vocal cord augmentation
ApplicantMENTOR CORP.
PMA NumberN16420
Supplement NumberS005
Date Received12/26/2000
Decision Date05/30/2001
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 a manufacturing site located at mentor corporation, minneapolis, mn, and approval for two sterilization sites located at steris isomedix, inc. , minneapolis, mn, and biotest laboratories, inc. , minneapolis, mn.
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