PMA P990004S015

Device: SURGIFOAM ABSORBABLE GELATIN SPONGE
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S015
Product code: LMF
Decision date: 2008-10-03
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: 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.

Current openFDA PMA Record#

Device: SURGIFOAM ABSORBABLE GELATIN SPONGE
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S015
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2008-10-03
Decision code: OK30
Date received: 2008-09-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 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.