- Device
- SURGIFLO HEMOSTATIC MATRIX
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S022
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2012-07-18
- Decision code
- APPR
- Date received
- 2012-06-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CHANGE IN THE WORDING OF THE INDICATION FOR USE STATEMENT.PRIOR IFU: SURGIFLO HEMOSTATIC MATRIX, MIXED WITH STERILE SALINE OR THROMBIN SOLUTION, IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARLERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL. NEW IFU: SURGIFLO HEMOSTATIC MATRIX, MIXED WITH STERILE SALINE OR THROMBIN SOLUTION,IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR OTHER CONVENTIONAL METHODS IS INEFFECTIVE OR IMPRACTICAL.