PMA P990004S019
- Device
- SURGIFOAM HEMOSTATIC MATRIX AND SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S019
- Product code
- LMF
- Decision date
- 2011-05-17
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF A NEW HEMOSTATIC MATRIX FORMULATION, REDESIGN OF THE APPLICATION COMPONENTS, REORGANIZATION OF THE PACKAGING, AND ADDITION OF EVITHROM LYOPHILIZED THROMBIN LABELING DIRECTLY INTO THE DIRECTIONS FOR USE AS WELL AS OTHER UPDATED LABELING CHANGES.
Current openFDA PMA Record#
- Device
- SURGIFOAM HEMOSTATIC MATRIX AND SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S019
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2011-05-17
- Decision code
- APPR
- Date received
- 2010-10-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF A NEW HEMOSTATIC MATRIX FORMULATION, REDESIGN OF THE APPLICATION COMPONENTS, REORGANIZATION OF THE PACKAGING, AND ADDITION OF EVITHROM LYOPHILIZED THROMBIN LABELING DIRECTLY INTO THE DIRECTIONS FOR USE AS WELL AS OTHER UPDATED LABELING CHANGES.