- Device
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Dental Sponge, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Hemorrhoidect
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S051
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2021-12-21
- Decision code
- OK30
- Date received
- 2021-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the Electron beam (E-beam) equipment located at the current E-beam contract sterilization site for the SURGIFOAM® Absorbable Gelatin Dental Sponge, the SURGIFOAM® Absorbable Gelatin Hemorrhoidectomy Sponge, and the SURGIFOAM® Absorbable Gelatin Powder.