PMA P990009S036

Device: FLOSEAL HEMOSTATIC MATRIX
Applicant: Baxter Healthcare Corp
PMA number: P990009
Supplement: S036
Product code: LMF
Decision date: 2013-06-19
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR INCLUSION OF AN ADDITIONAL PRECAUTION STATEMENT IN THE INSTRUCTIONS FOR USE FOR THE FLOSEAL HEMOSTATIC MATRIX ('FLOSEAL').

Current openFDA PMA Record#

Device: FLOSEAL HEMOSTATIC MATRIX
Applicant: Baxter Healthcare Corp
PMA number: P990009
Supplement: S036
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2013-06-19
Decision code: APPR
Date received: 2013-05-20
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR INCLUSION OF AN ADDITIONAL PRECAUTION STATEMENT IN THE INSTRUCTIONS FOR USE FOR THE FLOSEAL HEMOSTATIC MATRIX ('FLOSEAL').