SURGIFOAM HEMOSTATIC MATRIX AND SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
FDA premarket approval P990004/S019 · decided 2011-05-17
Approval details
- PMA number
- P990004
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGIFOAM HEMOSTATIC MATRIX AND SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2010-10-18
- Decision date
- 2011-05-17
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- 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.
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