SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.

FDA premarket approval P990004/S070 · decided 2025-01-27

Approval details

PMA number

P990004

Supplement

S070

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.

Generic name

Agent, absorbable hemostatic, collagen based

Applicant

Ferrosan Meidcal Devices A/S

Date received

2024-12-30

Decision date

2025-01-27

Days to decision

28 days

Decision code

OK30

Product code

LMF

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Soeborg

Statement

for the qualification of an expansion of the cleanroom capacity (Basis Expansion) at Ferrosan Medical Devices A/S (FeMD).