SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
FDA premarket approval P990004/S025 · decided 2016-05-16
Approval details
- PMA number
- P990004
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2014-10-24
- Decision date
- 2016-05-16
- Days to decision
- 570 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for a packaging change to introduce a new packaging configuration for the Thrombin Kit Package for SURGIFLO Hemostatic Matrix Kit with Thrombin. This change was requested for the manufacturing site located at SteriPack Medical Poland SP. ZO.O., Poland, for the contract packaging of the SURGIFLO Hemostatic Matrix Device and the sterilizing site located at Synergy Health Ede BV, Netherlands, for the sterilization of the SURGIFLO Hemostatic Matrix Device.
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