PMA P810006S072

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S072
Product code: LMF
Decision date: 2016-06-22
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Create a new procedure, Cutting and Inspection Procedure - ACS, for the cutting and inspection of Absorbable Collagen Sponge (ACS)-(EU) used as a component of the InductOs marketed in the European Union (EU) product in room 304, 105 Morgan Lane, Plainsboro, New Jersey. This procedure directs operators to cull out and reject any cut collagen sponge that has visible foreign matter embedded in or on the surface of the collagen sponge during the inspection process. In addition, a procedure, Packaging of ACS Sponge 3”x 4” or 1”x 2” 6-Pack or 1”x 2” 2-Packs on the Belco Sealer # 2, has been revised to direct operators to reject packaged product that has visible foreign matter on the product or inside the primary or secondary packaging.

Current openFDA PMA Record#

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S072
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2016-06-22
Decision code: OK30
Date received: 2016-05-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Create a new procedure, Cutting and Inspection Procedure - ACS, for the cutting and inspection of Absorbable Collagen Sponge (ACS)-(EU) used as a component of the InductOs marketed in the European Union (EU) product in room 304, 105 Morgan Lane, Plainsboro, New Jersey. This procedure directs operators to cull out and reject any cut collagen sponge that has visible foreign matter embedded in or on the surface of the collagen sponge during the inspection process. In addition, a procedure, Packaging of ACS Sponge 3”x 4” or 1”x 2” 6-Pack or 1”x 2” 2-Packs on the Belco Sealer # 2, has been revised to direct operators to reject packaged product that has visible foreign matter on the product or inside the primary or secondary packaging.