PMA P940016S009

Device: B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S009
Product code: MMY
Decision date: 2002-09-20
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: APPROVAL FOR 1) THE TRANSFER OF THE STERILIZATION PROCESS FOR THE BLOOD TUBING LINE COMPONENT OF B. BRAUN MEDICAL, INC.'S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM FROM ITS CURRENT, PMA APPROVED LOCATION TO THE B. BRAUN CAREX S.P.A. FACILITY; AND 2) THE PROPOSAL TO STERILIZE THE BLOOD TUBING LINES USING 10 PERCENT ETHYLENE OXIDE (ETO) AND 90 PERCENT CARBON DIOXIDE (CO2).

Current openFDA PMA Record#

Device: B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S009
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 2002-09-20
Decision code: APPR
Date received: 2002-06-07
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR 1) THE TRANSFER OF THE STERILIZATION PROCESS FOR THE BLOOD TUBING LINE COMPONENT OF B. BRAUN MEDICAL, INC.'S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM FROM ITS CURRENT, PMA APPROVED LOCATION TO THE B. BRAUN CAREX S.P.A. FACILITY; AND 2) THE PROPOSAL TO STERILIZE THE BLOOD TUBING LINES USING 10 PERCENT ETHYLENE OXIDE (ETO) AND 90 PERCENT CARBON DIOXIDE (CO2).