PMA P990009S037

Device: FLOSEAL HEMOSTATIC MATRIX
Applicant: Baxter Healthcare Corp
PMA number: P990009
Supplement: S037
Product code: LMF
Decision date: 2014-05-27
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR REVISED LABELING TO INCLUDE A SUMMARY OF THE NASSO ET AL. CLINICAL TRIAL, UPDATE THE DEVICE DESCRIPTION, AND EXTEND THE THROMBIN RECONSTITUTION PERIOD.

Current openFDA PMA Record#

Device: FLOSEAL HEMOSTATIC MATRIX
Applicant: Baxter Healthcare Corp
PMA number: P990009
Supplement: S037
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2014-05-27
Decision code: APPR
Date received: 2013-06-06
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISED LABELING TO INCLUDE A SUMMARY OF THE NASSO ET AL. CLINICAL TRIAL, UPDATE THE DEVICE DESCRIPTION, AND EXTEND THE THROMBIN RECONSTITUTION PERIOD.