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.
Baxter requests a transfer of the design-owning organization from baxter ag vienna, austria to baxter alliance park braine-l'alleud, belgium and final release testing and product release functions from baxter ag vienna, austria to baxter castlebar, ireland for the adept adhesion reduction solution.
| Device | ADEPT Adhesion Reduction Solution |
| Classification Name | Barrier, Absorbable, Adhesion |
| Generic Name | Barrier, Absorbable, Adhesion |
| Applicant | BAXTER HEALTHCARE CORP. |
| Date Received | 2017-05-17 |
| Decision Date | 2019-06-03 |
| PMA | P050011 |
| Supplement | S006 |
| Product Code | MCN |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location 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 |