POLYTEF PASTE FOR INJECTION

FDA Premarket Approval N16420 S005

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

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.

DevicePOLYTEF PASTE FOR INJECTION
Generic NamePaste, Injectable For Vocal Cord Augmentation
ApplicantCOLOPLAST CORP.
Date Received2000-12-26
Decision Date2001-05-30
PMAN16420
SupplementS005
Product CodeLTG 
Advisory CommitteeEar Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation 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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