PMA P990004S035
- Device
- SURGIFOAM Absorbable Gelatin Sponge
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S035
- Product code
- LMF
- Decision date
- 2019-07-17
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Approval for adding an additional production autoclave for terminal sterilization.
Current openFDA PMA Record#
- Device
- SURGIFOAM Absorbable Gelatin Sponge
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S035
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2019-07-17
- Decision code
- APPR
- Date received
- 2019-02-04
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for adding an additional production autoclave for terminal sterilization.