PMA P990004S010
- Device
- SURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S010
- Product code
- LMF
- Decision date
- 2006-10-03
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR AN ORAL SURGERY FORM OF SURGIFOAM ABSORBABLE GELATIN SPONGE, USP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE AND IS INDICATED FOR USE AS AN ADJUNCT TO HEMOSTASIS DURING SURGICAL PROCEDURES.
Current openFDA PMA Record#
- Device
- SURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S010
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2006-10-03
- Decision code
- APPR
- Date received
- 2006-08-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ORAL SURGERY FORM OF SURGIFOAM ABSORBABLE GELATIN SPONGE, USP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE AND IS INDICATED FOR USE AS AN ADJUNCT TO HEMOSTASIS DURING SURGICAL PROCEDURES.