SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absorbable Gelatin Powder Kit, SURGIFLO® Hemostatic Matrix, SURGIFLO® H
FDA premarket approval P990004/S058 · decided 2023-06-14
Approval details
- PMA number
- P990004
- Supplement
- S058
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absorbable Gelatin Powder Kit, SURGIFLO® Hemostatic Matrix, SURGIFLO® H
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2023-05-17
- Decision date
- 2023-06-14
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Change to the detergent used in the existing washing machine and to optimize the washing process of the washing machine used in the manufacturing of the SURGIFOAM® Powder and the SURGIFLO® Hemostatic Matrix products.
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