MACROPLASTIQUE IMPLANTS

Agent, Bulking, Injectable For Gastro-urology Use

FDA Premarket Approval P040050 S001

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 change from minneapolis, minnesota to minnetonka, minnesota.

DeviceMACROPLASTIQUE IMPLANTS
Classification NameAgent, Bulking, Injectable For Gastro-urology Use
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantUROPLASTY, LLC
Date Received2007-03-02
Decision Date2007-07-27
PMAP040050
SupplementS001
Product CodeLNM
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address UROPLASTY, LLC 5420 Feltl Road minnetonka, MN 55343

Supplemental Filings

Supplement NumberDateSupplement Type
P040050Original Filing
S012 2019-04-17 Normal 180 Day Track
S011 2014-08-19 30-day Notice
S010 2012-10-03 Normal 180 Day Track
S009
S008 2011-05-02 30-day Notice
S007 2010-11-24 Normal 180 Day Track No User Fee
S006
S005 2010-06-03 30-day Notice
S004 2009-10-23 30-day Notice
S003 2009-02-18 Normal 180 Day Track No User Fee
S002 2007-08-22 Normal 180 Day Track No User Fee
S001 2007-03-02 Normal 180 Day Track No User Fee

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