|
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 | S042 |
Date Received | 06/02/2016 |
Decision Date | 11/22/2016 |
Product Code |
PMX |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for artwork changes to the exterior of the product syringes, removal of a colorant clarifier from the syringe plunger, and addition of a black colorant to the plunger tip of the mixing syringe in order to support the addition of an alternative syringe supplier. |