- Device
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Hemorrhoidectomy Sponge/Oral Sponge and SURGIFOAM® Absorbable Gelatin Powd
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S047
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2021-04-30
- Decision code
- OK30
- Date received
- 2021-04-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the irradiation service location for the dose audit samples.