PMA P990009S013
- Device
- FLOSEAL HEMOSTATIC MATRIX
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S013
- Product code
- LMF
- Decision date
- 2005-03-10
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR AN ALTERNATE KIT CONFIGURATION THAT CONTAINS A HUMAN THROMBIN COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL HEMOSTATIC MATRIX AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
Current openFDA PMA Record#
- Device
- FLOSEAL HEMOSTATIC MATRIX
- Applicant
- Baxter Healthcare Corp
- PMA number
- P990009
- Supplement
- S013
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2005-03-10
- Decision code
- APPR
- Date received
- 2002-11-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ALTERNATE KIT CONFIGURATION THAT CONTAINS A HUMAN THROMBIN COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL HEMOSTATIC MATRIX AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.