PMA P920014S008

Device: TCI HEARTMATE IP LVAS
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S008
Product code: DSQ
Decision date: 1999-03-25
Generic name: Ventricular (assist) bypass
Approval order statement: Approval to modify section 9.6 of the current directions for use to include instructions for adding an additional retaining suture from the Outflow Graft Screw Ring to the Outflow Elbow Screw Ring to secure the outflow graft and outflow conduit.

Current openFDA PMA Record

Device: TCI HEARTMATE IP LVAS
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S008
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1999-03-25
Decision code: APPR
Date received: 1999-03-17
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to modify section 9.6 of the current directions for use to include instructions for adding an additional retaining suture from the Outflow Graft Screw Ring to the Outflow Elbow Screw Ring to secure the outflow graft and outflow conduit.