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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 W. River Rd. N.
Plymouth, MN 55411
PMA NumberN16420
Supplement NumberS007
Date Received12/09/2004
Decision Date01/03/2005
Withdrawal Date10/02/2009
Product Code LTG 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN VENDOR OF A RAW MATERIAL FOR POLYTEF PASTE FOR INJECTION.
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