PMA P990004S026

Device: SURGIFOAM ABSORBABLE GELATIN SPONGE USP
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S026
Product code: LMF
Decision date: 2015-03-17
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: CHANGES TO THE SAMPLING FREQUENCY USED FOR THE IN-PROCESS VISUAL INSPECTION, BARCODE SCANNING AND VACUUM TESTING PERFORMED ON THE SURGIFOAM PACKAGING.

Current openFDA PMA Record#

Device: SURGIFOAM ABSORBABLE GELATIN SPONGE USP
Applicant: Ferrosan Meidcal Devices A/S
PMA number: P990004
Supplement: S026
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2015-03-17
Decision code: OK30
Date received: 2015-02-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE SAMPLING FREQUENCY USED FOR THE IN-PROCESS VISUAL INSPECTION, BARCODE SCANNING AND VACUUM TESTING PERFORMED ON THE SURGIFOAM PACKAGING.