PMA P990004S004
- Device
- SURGIFOAM ABSORBABLE GELATIN POWDER
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S004
- Product code
- LMF
- Decision date
- 2002-09-25
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR MARKETING A POWDERED FORM OF THE ABSORBABLE GELATIN SPONGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN POWDER (MADE FROM ABSORBABLE GELATIN SPONGE, USP) AND IS INDICATED FOR VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
Current openFDA PMA Record#
- Device
- SURGIFOAM ABSORBABLE GELATIN POWDER
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S004
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2002-09-25
- Decision code
- APPR
- Date received
- 2002-08-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MARKETING A POWDERED FORM OF THE ABSORBABLE GELATIN SPONGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN POWDER (MADE FROM ABSORBABLE GELATIN SPONGE, USP) AND IS INDICATED FOR VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.