DURASPHERE INJECTABLE BULKING AGENT

Agent, Bulking, Injectable For Gastro-urology Use

FDA Premarket Approval P980053 S013

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

Addition of a new controlled environment area.

• Device: DURASPHERE INJECTABLE BULKING AGENT
• Classification Name: Agent, Bulking, Injectable For Gastro-urology Use
• Generic Name: Agent, Bulking, Injectable For Gastro-urology Use
• Applicant: CARBON MEDICAL TECHNOLOGIES, INC.
• Date Received: 2010-12-23
• Decision Date: 2011-01-20
• PMA: P980053
• Supplement: S013
• 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: CARBON MEDICAL TECHNOLOGIES, INC. 1290 Hammond Rd. st. Paul, MN 55110-5876

Supplemental Filings

Supplement Number	Date	Supplement Type
P980053		Original 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 ID	PMA	Supp
00858015005004	P980053	003
00858015005011	P980053	005