PMA P940016S001

Device: HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S001
Product code: MMY
Decision date: 1999-04-26
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: Approval for a change in the potting resin material (i.e., from polypropylene Valtech (Montell) HH-44 to polypropylene Pro-Fax PH920S) used to seal the end caps of the H.E.L.P. System Precipitate Filter.

Current openFDA PMA Record#

Device: HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM
Applicant: B. Braun Avitum AG
PMA number: P940016
Supplement: S001
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 1999-04-26
Decision code: APPR
Date received: 1998-11-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change in the potting resin material (i.e., from polypropylene Valtech (Montell) HH-44 to polypropylene Pro-Fax PH920S) used to seal the end caps of the H.E.L.P. System Precipitate Filter.