PMA P810006S021

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE AND FIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S021
Product code: LMF
Decision date: 2003-05-05
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: CHANGES EFFECTING MANUFACTURING PROCESSES INCLUDING: 1) QUALIFYING ADDITIONAL SPACE IN THE SAME FACILITY FOR THE ENZYME TREATMENT PROCESS USING THE SAME DEDICATED EQUIPMENT, 2) EQUIPPING THE ALKALI TREATMENT PROCESSING VESSELS WITH A DEDICATED TEMPERATURE PROBE AND CHART RECORDER TO CONTINUOUSLY MONITOR AND RECORD PRODUCT IN THE VESSELS DURING PROCESSING, 3) USE OF AN ADDITIONAL MANUFACTURING AREA, AND 4) USING A MICROWAVE MOISTURE ANALYZER, INSTEAD OF A DRY HEAT OVEN, FOR DRYING THE WEIGHTED SAMPLES OF ALKALI TREATED COLLAGEN SLICES.

Current openFDA PMA Record#

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE AND FIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S021
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2003-05-05
Decision code: OK30
Date received: 2003-04-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES EFFECTING MANUFACTURING PROCESSES INCLUDING: 1) QUALIFYING ADDITIONAL SPACE IN THE SAME FACILITY FOR THE ENZYME TREATMENT PROCESS USING THE SAME DEDICATED EQUIPMENT, 2) EQUIPPING THE ALKALI TREATMENT PROCESSING VESSELS WITH A DEDICATED TEMPERATURE PROBE AND CHART RECORDER TO CONTINUOUSLY MONITOR AND RECORD PRODUCT IN THE VESSELS DURING PROCESSING, 3) USE OF AN ADDITIONAL MANUFACTURING AREA, AND 4) USING A MICROWAVE MOISTURE ANALYZER, INSTEAD OF A DRY HEAT OVEN, FOR DRYING THE WEIGHTED SAMPLES OF ALKALI TREATED COLLAGEN SLICES.