PMA P910018S001

Device: LIPOSORBER LA-15 SYSTEM
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S001
Product code: MMY
Decision date: 1999-10-29
Classification: Lipoprotein, Low Density, Removal
Generic name: Lipoprotein, low density, removal
Approval order statement: Approval for the following changes: 1) replacing the Membrane Filter Unit (MFU) located in the Liposorber LA-15 adsorption column, with the Cardioplegia Supor-1220 filter, which is bonded to the Extracoporeal Blood Tubing System, LT-MA2; 2) removing the maintenance unit and adding a clamp valve cover plate to the MA-01 Apheresis Unit; 3) making nine software changes, most of which are intended to either simplify procedures, ease the display of treatment parameters, or to make the therapy safer for the patients; and, 4) revising the Operators' Manual to incorporate the revisions associated with the hardware and software changes.

Current openFDA PMA Record#

Device: LIPOSORBER LA-15 SYSTEM
Applicant: Kaneka Pharma America Corp.
PMA number: P910018
Supplement: S001
Product code: MMY
Generic name: Lipoprotein, low density, removal
Decision date: 1999-10-29
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 the following changes: 1) replacing the Membrane Filter Unit (MFU) located in the Liposorber LA-15 adsorption column, with the Cardioplegia Supor-1220 filter, which is bonded to the Extracoporeal Blood Tubing System, LT-MA2; 2) removing the maintenance unit and adding a clamp valve cover plate to the MA-01 Apheresis Unit; 3) making nine software changes, most of which are intended to either simplify procedures, ease the display of treatment parameters, or to make the therapy safer for the patients; and, 4) revising the Operators' Manual to incorporate the revisions associated with the hardware and software changes.