SURGIFOAM ABSORBABLE GELATIN SPONGE, SURGIFLO HEMOSTATIC MATRIX
FDA premarket approval P990004/S011 · decided 2007-04-13
Approval details
- PMA number
- P990004
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGIFOAM ABSORBABLE GELATIN SPONGE, SURGIFLO HEMOSTATIC MATRIX
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2007-03-19
- Decision date
- 2007-04-13
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- APPROVAL FOR A LABELING CHANGE ALLOWING WORDING THAT WILL RECOMMEND THE DRAWING OF 2 TO 5 ML SALINE OR THROMBIN FOR USE WITH SURGIFLO HEMOSTATIC MATRIX.
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