SURGIFOAM ABSORBABLE GELATIN HEMORRHOIDECTOMY SPONGE
FDA premarket approval P990004/S003 · decided 2000-11-15
Approval details
- PMA number
- P990004
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGIFOAM ABSORBABLE GELATIN HEMORRHOIDECTOMY SPONGE
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2000-10-02
- Decision date
- 2000-11-15
- Days to decision
- 44 days
- Decision code
- APPR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- 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
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