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.
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.
| Device | ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION |
| Classification Name | Barrier, Absorbable, Adhesion |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | BAXTER HEALTHCARE CORP. |
| Date Received | 2005-03-16 |
| Decision Date | 2006-07-28 |
| Notice Date | 2006-08-17 |
| PMA | P050011 |
| Supplement | S |
| Product Code | MCN |
| Docket Number | 06M-0322 |
| Advisory Committee | Obstetrics/Gynecology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAXTER HEALTHCARE CORP. 1620 Waukegan Road mcgaw Park, IL 60085 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050011 | Original Filing | |
| S008 | 2020-04-13 | Real-time Process |
| S007 | 2020-04-03 | Real-time Process |
| S006 | 2017-05-17 | Normal 180 Day Track No User Fee |
| S005 | 2013-08-02 | Real-time Process |
| S004 | 2013-06-06 | 30-day Notice |
| S003 | 2012-04-24 | Special (immediate Track) |
| S002 | 2010-11-03 | 135 Review Track For 30-day Notice |
| S001 | 2008-01-09 | 30-day Notice |