PMA P990004S075
- Device
- SURGIFLO® Hemostatic Matrix; SURGIFLO® Hemostatic Matrix Kit with Thrombin
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S075
- Product code
- LMF
- Decision date
- 2025-07-18
- Classification
- General, Plastic Surgery
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- the use of ovens for the manufacturing of SURGIFLO
Current openFDA PMA Record#
- Device
- SURGIFLO® Hemostatic Matrix; SURGIFLO® Hemostatic Matrix Kit with Thrombin
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S075
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2025-07-18
- Decision code
- OK30
- Date received
- 2025-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the use of ovens for the manufacturing of SURGIFLO