PMA P990004S076

Device: SURGIFOAM® Absorbable Gelatin Sponge
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S076
Product code: LMF
Decision date: 2025-09-08
Classification: General, Plastic Surgery
Generic name: Agent, absorbable hemostatic, collagen based
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).

Current openFDA PMA Record#

Device: SURGIFOAM® Absorbable Gelatin Sponge
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S076
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2025-09-08
Decision code: OK30
Date received: 2025-08-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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).