|
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 | S043 |
Date Received | 08/19/2016 |
Decision Date | 09/14/2016 |
Product Code |
PMX |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for labeling changes to enhance the safety of your device, including removal of the phrase spurting from bleeding types for which use of the device is described as effective in the warnings section of the labeling. |