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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMENTOR POLYTEF PASTE /FOR INJECTION
Generic NamePASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
ApplicantCOLOPLAST CORP.
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS, MN 55411
PMA NumberN16420
Supplement NumberS006
Date Received10/26/2001
Decision Date11/21/2001
Withdrawal Date 10/02/2009
Product Code LTG 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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