|
Device | ADEPT Adhesion Reduction Solution |
Generic Name | Barrier, absorbable, adhesion |
Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD MCGAW PARK, IL 60085 |
PMA Number | P050011 |
Supplement Number | S006 |
Date Received | 05/17/2017 |
Decision Date | 06/03/2019 |
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 Granted? | No |
Combination Product | No |
Approval Order Statement Approval for 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. |