Durasphere Injectable Bulking Agent

FDA Premarket Approval P980053 S019

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

DeviceDurasphere Injectable Bulking Agent
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantCARBON MEDICAL TECHNOLOGIES, INC.1290 Hammond Rd.st. Paul, MN 55110-5876 PMA NumberP980053 Supplement NumberS019 Date Received09/27/2022 Decision Date10/27/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-09-27
Decision Date2022-10-27
PMAP980053
SupplementS019
Product CodeLNM 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressCARBON MEDICAL TECHNOLOGIES, INC.
1290 Hammond Rd.
st. Paul, MN 55110-5876 PMA NumberP980053 Supplement NumberS019 Date Received09/27/2022 Decision Date10/27/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Change In The Sterilization Process Parameters Within The Existing Sterilization Facility

Supplemental Filings

Supplement NumberDateSupplement Type
P980053Original Filing
S019 2022-09-27 30-day Notice
S018 2020-12-28 Normal 180 Day Track No User Fee
S017 2019-08-01 30-day Notice
S016 2016-03-09 Special (immediate Track)
S015 2013-07-22 30-day Notice
S014 2013-02-19 30-day Notice
S013 2010-12-23 30-day Notice
S012
S011 2007-12-11 30-day Notice
S010 2006-02-23 30-day Notice
S009 2005-01-06 Normal 180 Day Track No User Fee
S008 2004-12-22 Normal 180 Day Track
S007 2004-06-29 Normal 180 Day Track
S006 2003-03-07 Normal 180 Day Track
S005 2002-11-29 Normal 180 Day Track
S004 2002-02-26 Normal 180 Day Track
S003 2001-03-12 Normal 180 Day Track
S002 2001-01-09 30-day Notice
S001 2000-10-06 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00858015005004 P980053 003
00858015005011 P980053 005

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