PMA P990004S031

Device: SURGIFOAM Absorbable Gelatin Sponge
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S031
Product code: LMF
Decision date: 2017-05-30
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Update the location of the Biological Indicator used during the sterilization validation of the Thrombin Kit Package of Product Code 2994 from the current location of under the flip-top-seal to the new location of next to the Thrombin vial.

Current openFDA PMA Record#

Device: SURGIFOAM Absorbable Gelatin Sponge
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S031
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2017-05-30
Decision code: OK30
Date received: 2017-05-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Update the location of the Biological Indicator used during the sterilization validation of the Thrombin Kit Package of Product Code 2994 from the current location of under the flip-top-seal to the new location of next to the Thrombin vial.