|
Device | FLOSEAL HEMOSTATIC MATRIX |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | BAXTER HEALTHCARE CORP. 32650 N WILSON RD ROUND LAKE, IL 60073 |
PMA Number | P990009 |
Supplement Number | S034 |
Date Received | 03/06/2012 |
Decision Date | 07/25/2012 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES TO THE FLOSEAL HEMOSTATIC MATRIX10ML KIT CONFIGURATION: INCLUSION OF MALLEABLE TIP; APPLICATOR; MODIFIED BOWL; PRE-FILLED SYRINGE OF SODIUM CHLORIDE SOLUTION; VIAL OF THROMBIN (5000 UNITS); AND INCLUSION OF A NEEDLE-FREE VIAL ADAPTER. |