PMA P990004S050
- Device
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S050
- Product code
- LMF
- Decision date
- 2021-10-28
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Use of an additional dry oven for the SURGIFOAM® pouch-packed sponge products to increase production capacity.
Current openFDA PMA Record#
- Device
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S050
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2021-10-28
- Decision code
- OK30
- Date received
- 2021-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an additional dry oven for the SURGIFOAM® pouch-packed sponge products to increase production capacity.