PMA P990004S018

Device: SURGIFOAM ABSORBABLE GELATIN SPONGE
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S018
Product code: LMF
Decision date: 2010-07-28
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL TO CHANGE THE INSTRUCTIONS FOR USE TO ADD SPECIFIC DIRECTIONS FOR USE OF THE DEVICE IN ENDOSCOPIC AND/OR LAPAROSCOPIC PROCEDURES.

Current openFDA PMA Record#

Device: SURGIFOAM ABSORBABLE GELATIN SPONGE
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S018
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2010-07-28
Decision code: APPR
Date received: 2010-06-23
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO CHANGE THE INSTRUCTIONS FOR USE TO ADD SPECIFIC DIRECTIONS FOR USE OF THE DEVICE IN ENDOSCOPIC AND/OR LAPAROSCOPIC PROCEDURES.