SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin
FDA premarket approval P990004/S063 · decided 2023-09-18
Approval details
- PMA number
- P990004
- Supplement
- S063
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2023-08-28
- Decision date
- 2023-09-18
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Alternative packaging pattern of SURGIFLO Intermediates for sterilization in the manufacturing of the SURGIFLO® Haemostatic Matrix and the SURGIFLO® Haemostatic Matrix Kit with Thrombin.
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