|
Device | GELFOAM PLUS HEMOSTASIS KIT |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | PFIZER, INC. 235 EAST 42ND ST. NEW YORK, NY 10017 |
PMA Number | N18286 |
Supplement Number | S018 |
Date Received | 02/26/2009 |
Decision Date | 06/10/2009 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF CHANGES TO THE MANUFACTURING OF THE HUMAN THROMBIN COMPONENT OF THE GELFOAM PLUS HEMOSTASIS KIT THROUGH THE ADDITION OF A SOLVENT/ DETERGENT STEP (HUMAN THROMBIN VH S/D). THE THROMBIN IS TO BE MANUFACTURED AND SUPPLIED BY BAXTER HEALTHCARE CORPORATION. |