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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.
 
DevicePOLYTEF PASTE FOR INJECTION
Generic NamePASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
ApplicantCOLOPLAST CORP.
1601 WEST RIVER ROAD NORTH
MINNEAPOLIS, MN 55411
PMA NumberN16420
Supplement NumberS005
Date Received12/26/2000
Decision Date05/30/2001
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 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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