|
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 | S064 |
Date Received | 11/09/2020 |
Decision Date | 12/08/2020 |
Product Code |
PMX |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement to add an alternate supplier for sodium chloride used in FLOSEAL Hemostatic Matrix manufacturing |