SURGIFLO HEMOSTATIC MATRIX
FDA premarket approval P990004/S008 · decided 2005-05-05
Approval details
- PMA number
- P990004
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGIFLO HEMOSTATIC MATRIX
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2005-03-10
- Decision date
- 2005-05-05
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- APPROVAL FOR MARKETING A PRE-FILLED PASTE PREPARED FROM THE POWDERED FORM OF THE ABSORBABLE GELATIN SPONGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFLO HEMOSTATIC MATRIX AND IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT UROLOGIC AND OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
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