PMA P990009S035

Device: FLOSEAL HEMOSTATIC MATRIX
Applicant: Baxter Healthcare Corp
PMA number: P990009
Supplement: S035
Product code: LMF
Decision date: 2013-09-19
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APROVAL TO CHANGE THE WARNING STATEMENT `THE SAFETY AND EFFECTIVENESS HAS NOT BEEN ESTABLISHED IN CHILDREN UNDER 2 YEARS OF AGE AND PREGNANT WOMEN¿.

Current openFDA PMA Record#

Device: FLOSEAL HEMOSTATIC MATRIX
Applicant: Baxter Healthcare Corp
PMA number: P990009
Supplement: S035
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2013-09-19
Decision code: APPR
Date received: 2013-03-25
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APROVAL TO CHANGE THE WARNING STATEMENT `THE SAFETY AND EFFECTIVENESS HAS NOT BEEN ESTABLISHED IN CHILDREN UNDER 2 YEARS OF AGE AND PREGNANT WOMEN¿.