SURGIFLO HEMOSTATIC MATRIX
FDA premarket approval P990004/S022 · decided 2012-07-18
Approval details
- PMA number
- P990004
- Supplement
- S022
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGIFLO HEMOSTATIC MATRIX
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2012-06-18
- Decision date
- 2012-07-18
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- 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 (O
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