- Device
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S049
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2021-08-25
- Decision code
- APPR
- Date received
- 2021-07-26
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for implementation of a new additional strategy for monitoring of the endotoxin levels in raw materials, components, intermediates and finished products at Ferrosan Medical Devices A/S