PMA P990004S038
- Device
- SURGIFOAM Absorbable Gelatin Sponge, U.S.P.
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S038
- Product code
- LMF
- Decision date
- 2020-04-14
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- New pallet configuration for the Gamma irradiation of SURGIFLO Hemostatic Matrix Intermediate.
Current openFDA PMA Record#
- Device
- SURGIFOAM Absorbable Gelatin Sponge, U.S.P.
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S038
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2020-04-14
- Decision code
- OK30
- Date received
- 2020-03-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New pallet configuration for the Gamma irradiation of SURGIFLO Hemostatic Matrix Intermediate.