Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
Device | DURASPHERE INJECTABLE BULKING AGENT |
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Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. ST. PAUL, MN 55110-5876 |
PMA Number | P980053 |
Date Received | 12/31/1998 |
Decision Date | 09/13/1999 |
Product Code | LNM |
Docket Number | 99M-4278 |
Notice Date | 10/15/1999 |
Advisory Committee | Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement This device is indicated for use in the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). | |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling |
Supplements: | S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S013 S014 S015 S016 S017 S018 S019 S020 |