PMA P990004S003

Device: SURGIFOAM ABSORBABLE GELATIN HEMORRHOIDECTOMY SPONGE
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S003
Decision date: 2000-11-15
Approval order statement: 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.

Current openFDA PMA Record#

Device: SURGIFOAM ABSORBABLE GELATIN HEMORRHOIDECTOMY SPONGE
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S003
Decision date: 2000-11-15
Decision code: APPR
Date received: 2000-10-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: 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.