|
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 | S058 |
Date Received | 11/22/2019 |
Decision Date | 08/07/2020 |
Product Code |
PMX |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the removal of the lower limit for the syringe extrusion force as a lot-release specification for the 5mL and 10mL configurations of the Floseal Hemostatic Matrix (Floseal). |