Product code LMF

Device name: Agent, Absorbable Hemostatic, Collagen Based
Medical specialty: General, Plastic Surgery
Device class: 3
Regulation number: 878.4490
Review panel: SU
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
N17600S046	Avitene™ Flowable Collagen Hemostat	Davol Inc., Sub. C. R. Bard, Inc.	2026-05-11
P990004S079	SURGIFOAM® Absorbable Gelatin Sponge	Ferrosan Meidcal Devices A/S	2026-03-24
P990004S078	SURGIFOAM® Absorbable Gelatin Sponge	Ferrosan Meidcal Devices A/S	2026-02-11
P990004S077	SURGIFOAM Absorbable Gelatin Sponge, USP	Ferrosan Meidcal Devices A/S	2026-01-28
P990004S076	SURGIFOAM® Absorbable Gelatin Sponge	Ferrosan Meidcal Devices A/S	2025-09-08
P990004S075	SURGIFLO® Hemostatic Matrix; SURGIFLO® Hemostatic Matrix Kit with Thrombin	Ferrosan Meidcal Devices A/S	2025-07-18
P990004S073	SURGIFLO™ Hemostatic Matrix Kit with Thrombin	Ferrosan Meidcal Devices A/S	2025-07-09
N17600S043	Avitene Flowable Collagen Hemostat	Davol Inc., Sub. C. R. Bard, Inc.	2025-06-10
P990004S074	SURGIFOAM® Absorbable Gelatin Sponge	Ferrosan Meidcal Devices A/S	2025-05-27
N17600S044	Avitene™ Microfibrillar Collagen Hemostat	Davol Inc., Sub. C. R. Bard, Inc.	2025-05-20
P800002S033	Avitene Microfibrillar Collagen Hemostat	C.R. Bard, Inc.	2025-03-13
N17600S042	Avitene Microfibrillar Collagen Hemostat	Davol Inc., Sub. C. R. Bard, Inc.	2025-03-13
P990004S072	SURGIFOAM Absorbable Gelatin Powder; SURGIFOAM Absorbable Gelatin Powder	Ferrosan Meidcal Devices A/S	2025-03-06
P850010S115	Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form	Integra LifeSciences Corporation	2025-02-18
P810006S111	Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form	Integra LifeSciences Corporation	2025-02-18
P800002S032	AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB	C.R. Bard, Inc.	2025-02-18
N17600S041	AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT)	Davol Inc., Sub. C. R. Bard, Inc.	2025-02-18
P990004S071	SURGIFOAM Absorbable Gelatin Sponge, U.S.P.	Ferrosan Meidcal Devices A/S	2025-02-04
P990004S070	SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.	Ferrosan Meidcal Devices A/S	2025-01-27
P850010S114	Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form	Integra LifeSciences Corporation	2025-01-14
P990004S067	SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin	Ferrosan Meidcal Devices A/S	2024-12-30
N17600S040	Avitene Flowable Collagen Hemostat	Davol Inc., Sub. C. R. Bard, Inc.	2024-12-18
P990004S069	SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.	Ferrosan Meidcal Devices A/S	2024-10-15
P850010S113	Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent - Fibrillar Form	Integra LifeSciences Corporation	2024-08-29
P810006S110	Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Form	Integra LifeSciences Corporation	2024-08-29
P990004S068	SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin	Ferrosan Meidcal Devices A/S	2024-08-22
P850010S112	Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form	Integra LifeSciences Corporation	2024-08-22
P810006S109	Collastat™ Absorbable Collagen Hemostatic Sponge, Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Form	Integra LifeSciences Corporation	2024-08-22
P850010S111	Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent-Fibrillar Form	Integra LifeSciences Corporation	2024-07-24
P810006S108	Collastat™ Absorbable Collagen Hemostatic Sponge, Collastat™ Absorbable Collagen Hemostatic Agent-Microfibrillar Form (I	Integra LifeSciences Corporation	2024-07-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
15712123000646	SURGIFLO™ Hemostatic Matrix Kit with Thrombin	Ferrosan Medical Devices A/S	2026-01-05
00300091040016	GEL-FLOW™ NT	PHARMACIA & UPJOHN COMPANY LLC	2018-04-17
00085412086309	Gelfoam Plus	BAXTER HEALTHCARE CORPORATION	2017-12-21
00085412096124	Floseal Hemostatic Matrix	BAXTER HEALTHCARE CORPORATION	2017-10-09
00085412096100	Floseal Hemostatic Matrix	BAXTER HEALTHCARE CORPORATION	2017-10-09
00085412095165	Gelfoam Plus	BAXTER HEALTHCARE CORPORATION	2016-09-08
00085412095158	Gelfoam Plus	BAXTER HEALTHCARE CORPORATION	2016-09-08
00085412091006	Floseal Special Applicator Tips	BAXTER HEALTHCARE CORPORATION	2015-05-14
00801741010439	Avitene	Davol Inc.	2014-09-12
00801741000386	Avitene	Davol Inc.	2014-09-12
00801741010453	Avitene	Davol Inc.	2014-09-12
00801741010477	Avitene	Davol Inc.	2014-09-12
00801741010484	Avitene	Davol Inc.	2014-09-12
00801741010491	Avitene	Davol Inc.	2014-09-12
00801741010507	Avitene	Davol Inc.	2014-09-12
10705031003217	INSTAT* MCH Microfibrillar Collagen Hemostat	INTEGRA LIFESCIENCES PRODUCTION CORPORATION	2014-09-11
10705031003194	INSTAT* MCH Microfibrillar Collagen Hemostat	INTEGRA LIFESCIENCES PRODUCTION CORPORATION	2014-09-11
00381780000191	Helistat®	Integra Lifesciences Corporation	2014-09-11
00381780000207	Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE	Integra Lifesciences Corporation	2014-09-11
00381780000214	Helitene®	Integra Lifesciences Corporation	2014-09-11
00381780000221	Helitene®	Integra Lifesciences Corporation	2014-09-11
00801741010460	Avitene	Davol Inc.	2014-09-10
00801741010514	Avitene	Davol Inc.	2014-09-09
10300090433045	Gelfoam	PHARMACIA & UPJOHN COMPANY LLC	2014-09-01
10300090396050	Gelfoam	PHARMACIA & UPJOHN COMPANY LLC	2014-09-01
10300090353015	Gelfoam	PHARMACIA & UPJOHN COMPANY LLC	2014-09-01
10300090349032	Gelfoam	PHARMACIA & UPJOHN COMPANY LLC	2014-09-01
10300090342019	Gelfoam	PHARMACIA & UPJOHN COMPANY LLC	2014-09-01
10300090323018	Gelfoam	PHARMACIA & UPJOHN COMPANY LLC	2014-09-01
10300090315082	Gelfoam	PHARMACIA & UPJOHN COMPANY LLC	2014-09-01

Product code LMF

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