- Device
- SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S028
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2016-02-05
- Decision code
- APPR
- Date received
- 2015-03-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a manufacturing site located at SteriPack Medical Poland SP.ZO.O., Poland, for the contract packaging of the SURGIFLO Hemostatic Matrix Device and thesterilizing site located at Synergy Health Ede BV, Netherlands, for the sterilization of theSURGIFLO Hemostatic