Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: SURGIFOAM® Absorbable Gelatin Sponge
• Generic Name: Agent, absorbable hemostatic, collagen based
• Regulation Number: 878.4490
• Applicant: Ferrosan Meidcal Devices A/S; Sydmarken 5; Soeborg 08876
• PMA Number: P990004
• Supplement Number: S076
• Date Received: 08/11/2025
• Decision Date: 09/08/2025
• Product Code: LMF
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
the implementation of an additional Syringe Assembly machine to increase production capacity for SURGIFLOW™ Hemostatic Matrix Kit and SURGIFLOW™ Hemostatic Matrix Kit with Thrombin productsThe proposed change qualifies for 30-Day Notice because it involves:• Implementation and use of an additional Syringe Assembly machine.• Manufacturing method/process change only.• Capacity increase for existing products.This manufacturing change meets FDA criteria for 30-Day Notice submission because it's a manufacturing capacity addition that maintains identical product specifications without impacting intended device safety, effectiveness, or characteristics. The change is operational (additional assembly location) rather than modification (product alteration).