SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
FDA premarket approval P990004/S028 · decided 2016-02-05
Approval details
- PMA number
- P990004
- Supplement
- S028
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2015-03-06
- Decision date
- 2016-02-05
- Days to decision
- 336 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- 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
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