PMA P990004S025

Device

SURGIFLO HEMOSTATIC MATRIX KIT WITH THROMBIN

Applicant

Ferrosan Meidcal Devices A/S

PMA number

P990004

Supplement

S025

Product code

LMF

Decision date

2016-05-16

Classification

Agent, Absorbable Hemostatic, Collagen Based

Generic name

Agent, absorbable hemostatic, collagen based

Approval order 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.

Summary

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