PMA P990004S079
- Device
- SURGIFOAM® Absorbable Gelatin Sponge
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S079
- Product code
- LMF
- Decision date
- 2026-03-24
- Classification
- General, Plastic Surgery
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- change the ethylene oxide (EO) concentration during sterilization of the device
Current openFDA PMA Record#
- Device
- SURGIFOAM® Absorbable Gelatin Sponge
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S079
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2026-03-24
- Decision code
- OK30
- Date received
- 2026-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change the ethylene oxide (EO) concentration during sterilization of the device