|
Device | FLOSEAL Hemostatic Matrix |
Generic Name | Absorbable collagen hemostatic agent with thrombin |
Regulation Number | 878.4490 |
Applicant | BAXTER HEALTHCARE CORP. 32650 N WILSON RD ROUND LAKE, IL 60073 |
PMA Number | P990009 |
Supplement Number | S052 |
Date Received | 12/26/2018 |
Decision Date | 03/22/2019 |
Product Code |
PMX |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the qualification of a second ethylene oxide sterilization cycle of the thrombin pouch assemblies. |