PMA P990004S030
- Device
- Surgifoam Absorbable Gelatin Sponge, USP
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S030
- Product code
- LMF
- Decision date
- 2017-03-08
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Change in the ethylene oxide sterilization process and change in the biological indicator
Current openFDA PMA Record#
- Device
- Surgifoam Absorbable Gelatin Sponge, USP
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S030
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2017-03-08
- Decision code
- OK30
- Date received
- 2017-02-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the ethylene oxide sterilization process and change in the biological indicator