SURGIFOAM ABSORBABLE GELATIN POWDER
FDA premarket approval P990004/S004 · decided 2002-09-25
Approval details
- PMA number
- P990004
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGIFOAM ABSORBABLE GELATIN POWDER
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2002-08-23
- Decision date
- 2002-09-25
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- 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.
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