PMA P990004S048
- Device
- SURGIFOAM Absorbable Gelation Sponge, U.S.P.
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S048
- Product code
- LMF
- Decision date
- 2021-06-02
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Change to the supplier location of gamma irradiation services for dose audit samples.
Current openFDA PMA Record#
- Device
- SURGIFOAM Absorbable Gelation Sponge, U.S.P.
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S048
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2021-06-02
- Decision code
- OK30
- Date received
- 2021-05-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the supplier location of gamma irradiation services for dose audit samples.