PMA P990004S012
- Device
- SURGIFOAM ABSORBABLE GELATIN SPONGE
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S012
- Product code
- LMF
- Decision date
- 2007-12-13
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- 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.
Current openFDA PMA Record#
- Device
- SURGIFOAM ABSORBABLE GELATIN SPONGE
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S012
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2007-12-13
- Decision code
- APPR
- Date received
- 2007-06-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- 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.