PMA P990004S011

Device: SURGIFOAM ABSORBABLE GELATIN SPONGE, SURGIFLO HEMOSTATIC MATRIX
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S011
Product code: LMF
Decision date: 2007-04-13
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order 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.

Current openFDA PMA Record#

Device: SURGIFOAM ABSORBABLE GELATIN SPONGE, SURGIFLO HEMOSTATIC MATRIX
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S011
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2007-04-13
Decision code: APPR
Date received: 2007-03-19
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.