SURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic Matrix Kit with Thrombin
FDA premarket approval P990004/S066 · decided 2024-05-02
Approval details
- PMA number
- P990004
- Supplement
- S066
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic Matrix Kit with Thrombin
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2024-04-05
- Decision date
- 2024-05-02
- Days to decision
- 27 days
- Decision code
- OK30
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- using molding tool for the luer lock of syringes for the SURGIFLO® Hemostatic Matrix and SURGIFLO® Hemostatic Matrix Kit with Thrombin
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