|
Device | SOLESTA INJECTABLE GEL |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | Palette Life Sciences 27 East Cota Street Suite 402 Santa Barbara, CA 93101 |
PMA Number | P100014 |
Date Received | 04/09/2010 |
Decision Date | 05/27/2011 |
Product Code |
LNM |
Docket Number | 11M-0445 |
Notice Date | 06/15/2011 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT00605826
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE SOLESTA. THIS DEVICE IS INDICATED FOR THE TREATMENT OF FECAL INCONTINENCE IN PATIENTS 18 YEARS AND OLDER WHO HAVE FAILED CONSERVATIVE THERAPY (E.G., DIET, FIBER THERAPY, ANTI-MOTILITY MEDICATIONS). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S002 S003 S004 S015 S016 S009 S005 S006 S007 S008 S011 S012 S013 S019 S014 S017 S018 S021 S022 S026 S032 S030 S020 S027 S023 S024 S028 S025 S033 S034 S031 S029 S035 |