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Device | ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION |
Generic Name | Barrier, absorbable, adhesion |
Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD MCGAW PARK, IL 60085 |
PMA Number | P050011 |
Date Received | 03/16/2005 |
Decision Date | 07/28/2006 |
Product Code |
MCN |
Docket Number | 06M-0322 |
Notice Date | 08/17/2006 |
Advisory Committee |
Obstetrics/Gynecology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION. THE DEVICE IS INDICATED FOR USE INTRAPERIOTONEALLY AS AN ADJUNCT TO GOOD SURGICAL TECHNIQUE FOR THE REDUCTION OF POST-SURGICAL ADHESIONS IN PATIENTS UNDERGOING GYNECOLOGICAL LAPAROSCOPIC ADHESIOLYSIS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 |