SURGIFOAM ABSORBABLE GELATIN SPONGE

by ETHICON, INC.

On Oct 22, 2012, the FDA received a filing from ETHICON, INC. for a 135 review track for 30-day notice. On Jan 09, 2013, the SU review committee issued the following statement with the approval order:

APPROVAL FOR A CHANGE IN THE LOCATION OF THE FERROSAN MEDICAL DEVICES A/S (FEMD) TESTING LABORATORY IN SOEBORG, DENMARK.

The review and decision took 79 days.

Trade Name SURGIFOAM ABSORBABLE GELATIN SPONGE
Generic Name ABSORBABLE GELATIN SPONGE, USP
Applicant ETHICON, INC.
P990004
Contact ROUTE 22 WEST

SOMERVILLE, NJ, 08876
Product Code LMF

Previous Supplements

SupplementApprovals
S022
Jul 18, 2012
LABELING CHANGE - INDICATIONS (SPECIAL(IMMEDIATE TRACK))
APPROVAL FOR A CHANGE IN THE WORDING OF THE INDICATION FOR USE STATEMENT. PRIOR IFU: SURGIFLO HEMOSTATIC MATRIX, MIXED WITH STERILE SALINE OR THROMBIN SOLUTION, IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARLERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL. NEW IFU: SURGIFLO HEMOSTATIC MATRIX, MIXED WITH STERILE SALINE OR THROMBIN SOLUTION, IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR OTHER CONVENTIONAL METHODS IS INEFFECTIVE OR IMPRACTICAL.
S021
Mar 02, 2011
PROCESS CHANGE - OTHER (30-DAY NOTICE)
CHANGE IN PACKAGING LINE EQUIPMENT.
S019
May 17, 2011
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT (NORMAL 180 DAY TRACK)
APPROVAL FOR THE INTRODUCTION OF A NEW HEMOSTATIC MATRIX FORMULATION, REDESIGN OF THE APPLICATION COMPONENTS, REORGANIZATION OF THE PACKAGING, AND ADDITION OF EVITHROM LYOPHILIZED THROMBIN LABELING DIRECTLY INTO THE DIRECTIONS FOR USE AS WELL AS OTHER UPDATED LABELING CHANGES.
S018
Jul 28, 2010
LABELING CHANGE - INSTRUCTIONS (REAL-TIME PROCESS)
APPROVAL TO CHANGE THE INSTRUCTIONS FOR USE TO ADD SPECIFIC DIRECTIONS FOR USE OF THE DEVICE IN ENDOSCOPIC AND/OR LAPAROSCOPIC PROCEDURES.
S017
May 31, 2011
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT (REAL-TIME PROCESS)
APPROVAL FOR CHANGES TO THE RECONSTITUTION OF METHOD FOR THE THROMBIN COMPONENT AND MODIFIED THE METHOD OF MIXING WITH THE POWDERED GELATIN COMPONENT.
S016
Oct 02, 2009
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT (REAL-TIME PROCESS)
APPROVAL FOR PERMISSION TO MARKET THE SURGIFLO HEMOSTATIC MATRIX KIT CONSISTING OF THE SURGIFLO HEMOSTATIC MATRIX AND EVITHROM LYOPHILIZED HUMAN THROMBIN.
S015
Oct 03, 2008
PROCESS CHANGE: STERILIZATION (30-DAY NOTICE)
ELIMINATION OF STERILITY TESTING AS PART OF THE STERILITY RELEASE PROCEDURE. THE RESULTS OF BIOBURDEN TESTING AND DRY HEAT STERILIZATION PROCESS PARAMETERS WILL CONTINUE TO BE REVIEWED AS PART OF THE STERILITY RELEASE.
S014
Jul 25, 2008
PROCESS CHANGE: STERILIZATION (30-DAY NOTICE)
CHANGE IN THE LOAD CONFIGURATION FOR THE STERILIZATION PROCESS.
S013
Dec 27, 2007
LABELING CHANGE - INDICATIONS (NORMAL 180 DAY TRACK)
APPROVAL FOR THE REMOVAL OF THE UROLOGIC PROCEDURES EXCLUSION FROM THE INDICATIONS STATEMENT.
S012
Dec 13, 2007
LABELING CHANGE - INSTRUCTIONS (NORMAL 180 DAY TRACK)
APPROVAL FOR THE ADDITION OF CLINICAL RESULTS TO THE PRODUCT LABELING WITH AN UPDATE TO THE DIRECTIONS FOR USE TO ALLOW USE IN ENDOSCOPIC NASAL SINUS SURGERY AND ADDITION OF A BENDABLE APPLICATOR TIP (FLEXTIP). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P. AND IS INDICATED FOR AN ADJUNCT TO HEMOSTASIS DURING SURGICAL PROCEDURES.
S011
Apr 13, 2007
LABELING CHANGE - INSTRUCTIONS (REAL-TIME PROCESS)
APPROVAL FOR A LABELING CHANGE ALLOWING WORDING THAT WILL RECOMMEND THE DRAWING OF 2 TO 5 ML SALINE OR THROMBIN FOR USE WITH SURGIFLO HEMOSTATIC MATRIX.
S010
Oct 03, 2006
DESIGN CHANGE - MINOR (REAL-TIME PROCESS)
APPROVAL FOR AN ORAL SURGERY FORM OF SURGIFOAM ABSORBABLE GELATIN SPONGE, USP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE AND IS INDICATED FOR USE AS AN ADJUNCT TO HEMOSTASIS DURING SURGICAL PROCEDURES.
S009
Feb 02, 2006
DESIGN CHANGE - MINOR (REAL-TIME PROCESS)
APPROVAL FOR A 3 GRAM SIZE PACKAGE OF THE SURGIFOAM ABSORBABLE GELATIN POWDER.
S008
May 05, 2005
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER (REAL-TIME PROCESS)
APPROVAL FOR MARKETING A PRE-FILLED PASTE PREPARED FROM THE POWDERED FORM OF THE ABSORBABLE GELATIN SPONGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFLO HEMOSTATIC MATRIX AND IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT UROLOGIC AND OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
S007
Jan 07, 2005
PROCESS CHANGE: STERILIZATION (NORMAL 180 DAY TRACK NO USER FEE)
APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT ISOTRON PLC, SWINDON, UNITED KINGDOM.
S006
Jun 28, 2004
LABELING CHANGE - OTHER (REAL-TIME PROCESS)
APPROVAL FOR REVISION ON THE LABELING TO INCLUDE THE USE OF THE PRODUCT WITH THROMBIN.
S005
Jul 29, 2004
LOCATION CHANGE: STERILIZER (NORMAL 180 DAY TRACK NO USER FEE)
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM.
S004
Sep 25, 2002
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER (REAL-TIME PROCESS)
APPROVAL FOR MARKETING A POWDERED FORM OF THE ABSORBABLE GELATIN SPONGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN POWDER (MADE FROM ABSORBABLE GELATIN SPONGE, USP) AND IS INDICATED FOR VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
S003
Nov 15, 2000
DESIGN CHANGE - MINOR (REAL-TIME PROCESS)
APPROVAL FOR A NEW CONFIGURATION (HEMORRHOIDECTOMY SPONGE) OF THE ABSORBABLE GELATIN SPONGE, USP AS WELL AS A NEW BUBBLE WRAP PACKAGE, A CHANGE IN THE STERILIZATION PROCEDURE INVOLVING THE USE OF E-BEAM STERILIZATION, AND SOME MINOR CHANGES TO THE PACKAGE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM(R) ABSORBA LE GELATIN SPONGE, USP, HEMORRHOIDECTOMY SPONGE AND IS INDICATED FOR SURGICAL PROCEDURES (EXCEPT UROLOGIC AND OPHTHALMIC) FOR HEMOSTASIS, WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
S002
Feb 08, 2000
LABELING CHANGE - INDICATIONS (REAL-TIME PROCESS)
A change in the "Indications for Use" statement.
S001
Dec 02, 1999
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER (REAL-TIME PROCESS)
Approval for the addition of sponges 3mm and 7mm thick.
Sep 30, 1999
Approval for the SURGIFOAM Absorbable Gelatin Sponge, U.S.P. This device is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.