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.
Approval to implement the assay for detecting the amount of peptidoglycan (pg) in the icodextrin active pharmaceutical ingredient (api).
| Device | ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN) |
| Classification Name | Barrier, Absorbable, Adhesion |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | BAXTER HEALTHCARE CORP. |
| Date Received | 2010-11-03 |
| Decision Date | 2011-06-17 |
| PMA | P050011 |
| Supplement | S002 |
| Product Code | MCN |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAXTER HEALTHCARE CORP. 1620 Waukegan Road mcgaw Park, IL 60085 |
| 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 |