MENTOR POLYTEF PASTE FOR INJECTION

FDA Premarket Approval N16420 S007

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.

Pre-market Approval Supplement Details

Change in vendor of a raw material for polytef paste for injection.

DeviceMENTOR POLYTEF PASTE FOR INJECTION
Generic NamePaste, Injectable For Vocal Cord Augmentation
ApplicantCOLOPLAST CORP.
Date Received2004-12-09
Decision Date2005-01-03
PMAN16420
SupplementS007
Product CodeLTG 
Advisory CommitteeEar Nose & Throat
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address COLOPLAST CORP. 1601 West River Road North minneapolis, MN 55411

Supplemental Filings

Supplement NumberDateSupplement Type
N16420Original Filing
S007 2004-12-09 30-day Notice
S006 2001-10-26 Normal 180 Day Track
S005 2000-12-26 Normal 180 Day Track
S004 1992-12-24 Normal 180 Day Track
S003
S002
S001 1983-05-23 Normal 180 Day Track

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