PMA P990004S017
- Device
- SURGIFOAM HEMOSTATIC MATRIX KIT
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S017
- Product code
- LMF
- Decision date
- 2011-05-31
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR CHANGES TO THE RECONSTITUTION OF METHOD FOR THE THROMBIN COMPONENT AND MODIFIED THE METHOD OF MIXING WITH THE POWDERED GELATIN COMPONENT.
Current openFDA PMA Record#
- Device
- SURGIFOAM HEMOSTATIC MATRIX KIT
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S017
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2011-05-31
- Decision code
- APPR
- Date received
- 2010-03-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE RECONSTITUTION OF METHOD FOR THE THROMBIN COMPONENT AND MODIFIED THE METHOD OF MIXING WITH THE POWDERED GELATIN COMPONENT.