PMA P870072S035

Device: TLC-II PORTABLE VAD DRIVER
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S035
Product code: DSQ
Decision date: 2009-01-21
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE TLC-II PORTABLE VAD DRIVER, INCLUDING THE ADDITION OF A SCROLL COMPRESSOR, ELECTRONIC RVAD PRESSURE REGULATOR, LONGER PNEUMATIC LEADS REMOVAL OF CONTRAINDICATION AGAINST PATIENTS REQUIRING HIGH RVAD DRIVER PRESSURES AND/OR LONG EJECTION TIMES, AND ASSOCIATED HARDWARE AND SOFTWARE CHANGES.

Current openFDA PMA Record#

Device: TLC-II PORTABLE VAD DRIVER
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S035
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2009-01-21
Decision code: APPR
Date received: 2006-09-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE TLC-II PORTABLE VAD DRIVER, INCLUDING THE ADDITION OF A SCROLL COMPRESSOR, ELECTRONIC RVAD PRESSURE REGULATOR, LONGER PNEUMATIC LEADS REMOVAL OF CONTRAINDICATION AGAINST PATIENTS REQUIRING HIGH RVAD DRIVER PRESSURES AND/OR LONG EJECTION TIMES, AND ASSOCIATED HARDWARE AND SOFTWARE CHANGES.