SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin
FDA premarket approval P990004/S062 · decided 2023-08-31
Approval details
- PMA number
- P990004
- Supplement
- S062
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2023-08-07
- Decision date
- 2023-08-31
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for the amendments and additions to the Directions for Use, Storage and Handling, and Disposal section of the Instructions for Use sheet of the SURGIFLO® Hemostatic Matrix and the SURGIFLO® Hemostatic Matrix Kit with Thrombin.
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