PMA N18286S028

Device

GELFOAM

Applicant

Pfizer, Inc.

PMA number

N18286

Supplement

S028

Product code

LMF

Decision date

2018-03-01

Classification

Agent, Absorbable Hemostatic, Collagen Based

Generic name

Agent, absorbable hemostatic, collagen based

Approval order statement

Approval for an alternative packaging configuration for GELFOAM Sterile Powder under the trade name FLOSTAT NT as well as approval of the associated new manufacturing site for GELFOAM Sterile Powder manufacture (solely for FLOSTAT NT), kit assembly, secondary packaging, and sterilization at Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, Minnesota.

Summary

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