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.
Implementation of a new heat sealing instrument for final package manufacturing.
Device | MACROPLASTIQUE IMPLANTS |
Classification Name | Agent, Bulking, Injectable For Gastro-urology Use |
Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
Applicant | UROPLASTY, LLC |
Date Received | 2011-05-02 |
Decision Date | 2011-05-27 |
PMA | P040050 |
Supplement | S008 |
Product Code | LNM |
Advisory Committee | Gastroenterology/Urology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | UROPLASTY, LLC 5420 Feltl Road minnetonka, MN 55343 |
Supplement Number | Date | Supplement Type |
---|---|---|
P040050 | Original 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 |